Trial Outcomes & Findings for Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens (NCT NCT02864368)
NCT ID: NCT02864368
Last Updated: 2022-06-09
Results Overview
To assess the safety of PEP-CMV vaccination in combination with adjuvant TMZ, the percentage of patients with unacceptable toxicity will be estimated within each arm. All patients who received any PEP-CMV vaccine will be included in these analyses.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
2 weeks after the 3rd vaccine, which is approximately 12 weeks after consent
Results posted on
2022-06-09
Participant Flow
PEP-CMV vaccine originally was comprised of Component A (a pp65 synthetic long peptide \[SLP\]) and Component B (a neutralizing antibody epitope from human CMV glycoprotein B \[gB\] conjugated to KLH). Component B was removed due to insufficient manufacturing of Component B followed by hypersensitivity reactions in a subset of patients.
Participant milestones
| Measure |
5-day TMZ: Components A and B
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
21-day TMZ: Components A and B
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Safety Cohort
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Component A Alone
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
21-day TMZ: Component A Alone
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
6
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
1
|
6
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
Baseline characteristics by cohort
| Measure |
5-day TMZ: Components A and B
n=4 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
21-day TMZ: Components A and B
n=1 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Safety Cohort
n=6 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Component A Alone
n=8 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
21-day TMZ: Component A Alone
n=8 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.75 years
STANDARD_DEVIATION 8.14 • n=93 Participants
|
40 years
STANDARD_DEVIATION NA • n=4 Participants
|
57.33 years
STANDARD_DEVIATION 9.97 • n=27 Participants
|
57.63 years
STANDARD_DEVIATION 11.04 • n=483 Participants
|
50.25 years
STANDARD_DEVIATION 8.84 • n=36 Participants
|
55.19 years
STANDARD_DEVIATION 10.23 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
22 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after the 3rd vaccine, which is approximately 12 weeks after consentTo assess the safety of PEP-CMV vaccination in combination with adjuvant TMZ, the percentage of patients with unacceptable toxicity will be estimated within each arm. All patients who received any PEP-CMV vaccine will be included in these analyses.
Outcome measures
| Measure |
5-day TMZ: Components A and B
n=4 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
21-day TMZ: Components A and B
n=1 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Safety Cohort
n=6 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Component A Alone
n=8 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
21-day TMZ: Component A Alone
n=8 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-related Adverse Events
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1.5 yearsPopulation: Participants who received Component A alone as well as an assessment of immune response after receiving 3 vaccinations. Data not collected on Components A and B cohorts or the Safety Cohort.
The primary analysis will focus on patients who have follow-up immunologic monitoring after the 3rd vaccination with component A alone and before initiation of the second TMZ/vaccine cycle. Such a patient is considered "evaluable" for the immunologic response primary analyses. The Wilcoxon rank sum test will compare treatment groups with regard to the median peak number of T cells that secrete IFNγ by ELISPOT in response to component A of PEP-CMV. Analyses will include only those patients who have an assessment of immune response after receiving 3 vaccinations.
Outcome measures
| Measure |
5-day TMZ: Components A and B
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
21-day TMZ: Components A and B
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Safety Cohort
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Component A Alone
n=6 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
21-day TMZ: Component A Alone
n=4 Participants
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
|---|---|---|---|---|---|
|
Immunologic Response as Measured by Peak Number of T Cells That Secrete IFNγ by ELISPOT in Response to Component A of PEP-CMV
|
—
|
—
|
—
|
57.5 T cells
Interval 13.5 to 241.5
|
71.25 T cells
Interval 28.0 to 146.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1.5 yearsPopulation: No data collected with respect to this outcome. Tumor was not collected at the time of disease progression/recurrence.
To determine if tumors are CMV antigen negative by immunohistochemical analysis for the presence of the antigen pp65 at the time of disease progression/recurrence
Outcome measures
Outcome data not reported
Adverse Events
5-day TMZ: Components A and B
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
21-day TMZ: Components A and B
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
5-day TMZ: Safety Cohort
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
5-day TMZ: Component A Alone
Serious events: 6 serious events
Other events: 8 other events
Deaths: 8 deaths
21-day TMZ: Component A Alone
Serious events: 4 serious events
Other events: 8 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
5-day TMZ: Components A and B
n=4 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
21-day TMZ: Components A and B
n=1 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Safety Cohort
n=6 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Component A Alone
n=8 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
21-day TMZ: Component A Alone
n=8 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
General disorders
Chills
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
General disorders
Fever
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
General disorders
Flu like symptoms
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
50.0%
4/8 • 24 Months
|
50.0%
4/8 • 24 Months
|
|
Immune system disorders
Cytokine release syndrome
|
50.0%
2/4 • 24 Months
|
100.0%
1/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Infections and infestations
Infections and infestations - Other, Specify: PNEUMONIA
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Investigations
Investigations - Other, Specify: LACTIC ACIDOSIS
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
50.0%
4/8 • 24 Months
|
Other adverse events
| Measure |
5-day TMZ: Components A and B
n=4 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
21-day TMZ: Components A and B
n=1 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Safety Cohort
n=6 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered
|
5-day TMZ: Component A Alone
n=8 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\^2/day on days 1-5 of each 28 day cycle
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
21-day TMZ: Component A Alone
n=8 participants at risk
All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered
Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
General disorders
Chills
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
66.7%
4/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
General disorders
Edema limbs
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
General disorders
Fatigue
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
66.7%
4/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
General disorders
Fever
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
General disorders
General disorders and administration site conditions - Other, Specify: NIGHT SWEATS
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
General disorders
Injection site reaction
|
50.0%
2/4 • 24 Months
|
100.0%
1/1 • 24 Months
|
66.7%
4/6 • 24 Months
|
87.5%
7/8 • 24 Months
|
75.0%
6/8 • 24 Months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
83.3%
5/6 • 24 Months
|
75.0%
6/8 • 24 Months
|
62.5%
5/8 • 24 Months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Specify: CUT FACE SHAVING; BLED FOR 2+ HOURS
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
1/4 • 24 Months
|
100.0%
1/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
37.5%
3/8 • 24 Months
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Specify: "CLOGGED FEELING"
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Eye disorders
Eye disorders - Other, Specify: LEFT EYE WEEPY, RED, SWOLLEN, BLOOD SHOT
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Eye disorders
Eye disorders - Other, Specify: RED, ITCHY EYES
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Eye disorders
Eye disorders - Other, Specify: REDNESS
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Eye disorders
Eye disorders - Other, Specify: REQUIRES BRIGHTER LIGHTS WHEN INSIDE IN ORDER TO SEE
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Specify: CRAMPING
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
50.0%
3/6 • 24 Months
|
62.5%
5/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
General disorders
Pain
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Immune system disorders
Cytokine release syndrome
|
50.0%
2/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
83.3%
5/6 • 24 Months
|
75.0%
6/8 • 24 Months
|
50.0%
4/8 • 24 Months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Infections and infestations
Infections and infestations - Other, Specify: SHINGLES
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 24 Months
|
100.0%
1/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
37.5%
3/8 • 24 Months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Investigations
Lymphocyte count decreased
|
50.0%
2/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
50.0%
3/6 • 24 Months
|
87.5%
7/8 • 24 Months
|
62.5%
5/8 • 24 Months
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
66.7%
4/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
62.5%
5/8 • 24 Months
|
50.0%
4/8 • 24 Months
|
|
Investigations
White blood cell decreased
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
50.0%
3/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
62.5%
5/8 • 24 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
3/4 • 24 Months
|
100.0%
1/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
100.0%
8/8 • 24 Months
|
75.0%
6/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
50.0%
4/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
2/4 • 24 Months
|
100.0%
1/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
62.5%
5/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
50.0%
2/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
50.0%
4/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
37.5%
3/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Specify: NIGHT SWEATS
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other, Specify: SQUAMOUS CELL CARCINOMA
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
83.3%
5/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
25.0%
2/8 • 24 Months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
50.0%
3/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Nervous system disorders - Other, Specify: A LITTLE WOBBLY, OFF BALANCE
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Nervous system disorders - Other, Specify: HEMIANOPSIA
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Nervous system disorders - Other, Specify: QUADRANTANOPSIA
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
50.0%
4/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
33.3%
2/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
50.0%
4/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
25.0%
2/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Specify: "LUMP IN THROAT"
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Specify: "STRANGE SENSATION ON THROAT"
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Specify: DRY THROAT
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
37.5%
3/8 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: DARK CRUSTY SPOTS POSS. ACTINIC KERATOSIS
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: FEVER BLISTER
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
16.7%
1/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: POISON IVY
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: POSSIBLE PRECANCEROUS LESION
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
50.0%
2/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
50.0%
3/6 • 24 Months
|
50.0%
4/8 • 24 Months
|
62.5%
5/8 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
50.0%
4/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Vascular disorders
Hematoma
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
|
Vascular disorders
Hot flashes
|
25.0%
1/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
0.00%
0/8 • 24 Months
|
12.5%
1/8 • 24 Months
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
83.3%
5/6 • 24 Months
|
62.5%
5/8 • 24 Months
|
50.0%
4/8 • 24 Months
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 24 Months
|
0.00%
0/1 • 24 Months
|
0.00%
0/6 • 24 Months
|
12.5%
1/8 • 24 Months
|
0.00%
0/8 • 24 Months
|
Additional Information
Principal Investigator
Duke University Medical Center
Phone: (919) 684-5301
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place