Trial Outcomes & Findings for Vaccine Treatment of Kidney Cancer (NCT NCT00089778)
NCT ID: NCT00089778
Last Updated: 2017-08-01
Results Overview
Overall response is defined as the best response (e.g. complete response...) recorded from the start of treatment until disease progression/recurrence. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of LD of target lesions since the treatment started or the appearance of new lesion. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
3 years and 9 months
Results posted on
2017-08-01
Participant Flow
Participant milestones
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study).
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study).
|
Grp C - High-risk Loco-regional Disease
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant).
This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study).
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
8
|
|
Overall Study
COMPLETED
|
2
|
1
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study).
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study).
|
Grp C - High-risk Loco-regional Disease
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant).
This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Vaccine Treatment of Kidney Cancer
Baseline characteristics by cohort
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
n=2 Participants
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
n=1 Participants
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
|
Grp C - High-risk Loco-regional Disease
n=8 Participants
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
55.93 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
11 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 years and 9 monthsPopulation: Pts in Group C had no evaluable disease,response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).
Overall response is defined as the best response (e.g. complete response...) recorded from the start of treatment until disease progression/recurrence. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of LD of target lesions since the treatment started or the appearance of new lesion. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
n=2 Participants
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
n=1 Participants
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
|
Grp C - High-risk Loco-regional Disease
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)
|
|---|---|---|---|
|
Response
Progressive disease
|
2 Participants
|
1 Participants
|
—
|
|
Response
Complete response
|
0 Participants
|
0 Participants
|
—
|
|
Response
Partial Response
|
0 Participants
|
0 Participants
|
—
|
|
Response
Stable disease
|
0 Participants
|
0 Participants
|
—
|
|
Response
Not evaluable
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 47 monthsHere is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
n=2 Participants
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
n=1 Participants
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
|
Grp C - High-risk Loco-regional Disease
n=8 Participants
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)
|
|---|---|---|---|
|
Count of Participants With Adverse Events
|
2 Participants
|
1 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: "1 uM A3 culture vs tranfectant" means "Immune cells cultured with the concentration of 1 uM of the A3 peptide were tested against \[with\] target cells into which the FGF-5 target gene was inserted \[transfected with\] and the release of interferon is measured to detect immune recognition".Documentation was only available for the 4 patients.
FGF-5 specific CTL (cytotoxic T lymphocytes) may be tested by cytokine release assay or ELISPOT (enzyme linked immunosorbent spot) assay using tumor, FGF-5 transfected or peptide-loaded target cells and compared to pre-treatment peripheral blood mononuclear cells (PBMC) to determine immune response to vaccination. In the assays, differences of 2-3 fold are indicative of true biologic difference.Due to text data entry field limitations, Pre vaccination and post vaccination will be shown in the results as Pre V and Post V, respectively. Patients entered in Group A did not complete sufficient vaccinations to permit immunological evaluation and in Group B, the co-administration of IL-2 is known to corrupt immunological evaluation (so only clinical responses are valid). Expanding information on cancer vaccines in general as wells as preliminary information from this trial on FGF-5 as a vaccine target both served to render the enrollment of additional patients to this trial obsolete.
Outcome measures
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
n=4 Participants
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
|
Grp C - High-risk Loco-regional Disease
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)
|
|---|---|---|---|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #2 0.1µM culture A3/FGF-5
|
1424 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #3 1µM culture A3/gp100
|
3 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #1 1µM culture A3/gp100
|
0 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #1 1µM culture A3/FGF-5
|
0 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #1 1µM culture A3/gp100
|
0 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #1 1µM culture A3/FGF-5
|
1680 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #1 0.1µM culture A3/FGF-5
|
2620 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #1 0.01µM culture A3/FGF5
|
4760 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #1 1µM culture A3/gp100
|
0 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #1 1µM culture A3/FGF-5
|
826 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #1 0.1µM culture A3/FGF-5
|
891 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #1 0.01µM culture A3/FGF5
|
668 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #2 1µM culture A3/gp100
|
6 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #2 1µM culture A3/FGF-5
|
30 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #2FGF-5 culture vs transfectant
|
41 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #2 1µM culture A3/gp100
|
10 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #2 1µM culture A3/FGF-5
|
258 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #2FGF-5 culture vs transfectant
|
170 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #2 1µM culture A3/gp100
|
52 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #2FGF-5 culture vs transfectant
|
1000 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #3 1µM culture A3/gp100
|
2 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #3 1µM culture A3/FGF-5
|
1 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A3 pt #3FGF-5 culture vs transfectant
|
2 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #3 1µM culture A3/gp100
|
2 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #3 1µM culture A3/FGF-5
|
4 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A3 pt #3FGF-5 culture vs transfectant
|
2 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #3 0.1µM culture A3/FGF-5
|
9 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V2 A3 pt #3FGF-5 culture vs transfectant
|
5 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A2 pt #4 1µM culture A2/gp100
|
8 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A2 pt #4 1µM culture A2/FGF-5
|
1 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Pre V0 A2 pt #4FGF-5 culture vs transfectant
|
2 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A2 pt #4 1µM culture A2/gp100
|
2 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A2 pt #4 1µM culture A2/FGF-5
|
68 pg/ml/24 hrs
|
—
|
—
|
|
Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Post V1 A2 pt #4FGF-5 culture vs transfectant
|
206 pg/ml/24 hrs
|
—
|
—
|
Adverse Events
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Grp B - Measurable Metastatic Disease That Require Aldesleukin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Grp C - High-risk Loco-regional Disease
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
n=2 participants at risk
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
n=1 participants at risk
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
|
Grp C - High-risk Loco-regional Disease
n=8 participants at risk
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)
|
|---|---|---|---|
|
General disorders
Edema limbs
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Vascular disorders
Thrombosis
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
Other adverse events
| Measure |
Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)
n=2 participants at risk
Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
|
Grp B - Measurable Metastatic Disease That Require Aldesleukin
n=1 participants at risk
Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
|
Grp C - High-risk Loco-regional Disease
n=8 participants at risk
Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)
|
|---|---|---|---|
|
Investigations
Hemoglobin decreased
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Investigations
Activated partial thromboplastin time prolonged (aPTT)
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
100.0%
2/2 • Number of events 5 • 47 months
|
100.0%
1/1 • Number of events 4 • 47 months
|
100.0%
8/8 • Number of events 83 • 47 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • Number of events 2 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
General disorders
Edema limbs
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Metabolism and nutrition disorders
Creatinine increased
|
50.0%
1/2 • Number of events 2 • 47 months
|
100.0%
1/1 • Number of events 4 • 47 months
|
0.00%
0/8 • 47 months
|
|
Investigations
Serum magnesium increased
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
50.0%
1/2 • Number of events 1 • 47 months
|
100.0%
1/1 • Number of events 1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
100.0%
2/2 • Number of events 3 • 47 months
|
100.0%
1/1 • Number of events 3 • 47 months
|
12.5%
1/8 • Number of events 2 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Cardiac disorders
Chest pain
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 2 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Investigations
lymphocyte count decreased
|
0.00%
0/2 • 47 months
|
100.0%
1/1 • Number of events 4 • 47 months
|
0.00%
0/8 • 47 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • 47 months
|
100.0%
1/1 • Number of events 1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Immune system disorders
Rhinitis infective
|
0.00%
0/2 • 47 months
|
100.0%
1/1 • Number of events 1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Investigations
Bilirubin increased
|
0.00%
0/2 • 47 months
|
100.0%
1/1 • Number of events 2 • 47 months
|
0.00%
0/8 • 47 months
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/2 • 47 months
|
100.0%
1/1 • Number of events 1 • 47 months
|
0.00%
0/8 • 47 months
|
|
General disorders
Fever
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Investigations
Weight gain
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 2 • 47 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • 47 months
|
0.00%
0/1 • 47 months
|
12.5%
1/8 • Number of events 1 • 47 months
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 2 • 47 months
|
0.00%
0/1 • 47 months
|
0.00%
0/8 • 47 months
|
|
Investigations
serum calcium decreased
|
0.00%
0/2 • 47 months
|
100.0%
1/1 • Number of events 1 • 47 months
|
0.00%
0/8 • 47 months
|
Additional Information
James Yang, M.D.
National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-496-1574
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place