Trial Outcomes & Findings for GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma (NCT NCT00293423)
NCT ID: NCT00293423
Last Updated: 2021-05-13
Results Overview
MTD determination will be based on the occurrence of dose-limiting toxicities. The MTD will be 1 dose below the dose that defined the dose-limiting toxicities
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2021-05-13
Participant Flow
Phase 1 Recruitment took place between August 11, 2005 and July 25, 2007 for participants scheduled for gross total resection of recurrent Glioblastoma multiforme (GBM) Phase 2 Recruitment took place between October 3, 2007 and October 24, 2011 for participants scheduled for gross total resection of recurrent Glioblastoma multiforme (GBM)
Participant milestones
| Measure |
Phase 1: Vaccine
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
|
Phase 2: Vaccine
Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
|
|---|---|---|
|
Surgical Resection
STARTED
|
28
|
68
|
|
Surgical Resection
COMPLETED
|
12
|
41
|
|
Surgical Resection
NOT COMPLETED
|
16
|
27
|
|
Vaccination Treatment Period
STARTED
|
12
|
41
|
|
Vaccination Treatment Period
COMPLETED
|
12
|
38
|
|
Vaccination Treatment Period
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Phase 1: Vaccine
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
|
Phase 2: Vaccine
Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
|
|---|---|---|
|
Surgical Resection
Less than a 90% extent of resection
|
0
|
1
|
|
Surgical Resection
Postoperative Karnofsky Performance Score <70%
|
0
|
4
|
|
Surgical Resection
Insufficient tumor obtained to generate vaccine
|
9
|
13
|
|
Surgical Resection
disease progression prior to initial vaccination
|
2
|
9
|
|
Surgical Resection
processing error during surgical resection
|
1
|
0
|
|
Surgical Resection
Withdrawal by Subject
|
4
|
0
|
|
Vaccination Treatment Period
Received < 4 required vaccinations
|
0
|
3
|
Baseline Characteristics
Vaccines were only given to the intent-to-treat population
Baseline characteristics by cohort
| Measure |
Phase 1: Vaccine
n=28 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
|
Phase 2: Vaccine
n=68 Participants
Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years old
|
0 Participants
n=28 Participants
|
3 Participants
n=68 Participants
|
3 Participants
n=96 Participants
|
|
Age, Customized
30-39 years old
|
3 Participants
n=28 Participants
|
2 Participants
n=68 Participants
|
5 Participants
n=96 Participants
|
|
Age, Customized
40-49 years old
|
5 Participants
n=28 Participants
|
14 Participants
n=68 Participants
|
19 Participants
n=96 Participants
|
|
Age, Customized
50-59 years old
|
12 Participants
n=28 Participants
|
23 Participants
n=68 Participants
|
35 Participants
n=96 Participants
|
|
Age, Customized
60-69 years old
|
6 Participants
n=28 Participants
|
20 Participants
n=68 Participants
|
26 Participants
n=96 Participants
|
|
Age, Customized
70-79 years old
|
2 Participants
n=28 Participants
|
6 Participants
n=68 Participants
|
8 Participants
n=96 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=28 Participants
|
19 Participants
n=68 Participants
|
32 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=28 Participants
|
49 Participants
n=68 Participants
|
64 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=28 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=28 Participants
|
68 Participants
n=68 Participants
|
96 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=28 Participants
|
2 Participants
n=68 Participants
|
2 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=28 Participants
|
1 Participants
n=68 Participants
|
2 Participants
n=96 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=28 Participants
|
65 Participants
n=68 Participants
|
92 Participants
n=96 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=28 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=96 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
68 participants
n=68 Participants
|
96 participants
n=96 Participants
|
|
Median Number of Vaccine Doses Administered
|
6 vaccine injections
n=12 Participants • Vaccines were only given to the intent-to-treat population
|
6 vaccine injections
n=41 Participants • Vaccines were only given to the intent-to-treat population
|
6 vaccine injections
n=53 Participants • Vaccines were only given to the intent-to-treat population
|
PRIMARY outcome
Timeframe: Up to 4 weeksMTD determination will be based on the occurrence of dose-limiting toxicities. The MTD will be 1 dose below the dose that defined the dose-limiting toxicities
Outcome measures
| Measure |
Phase 1: Vaccine
n=12 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Maximum Tolerated Dose (MTD) (Phase 1)
|
25 micrograms
|
PRIMARY outcome
Timeframe: Up to 6 monthsThe frequency of dosing of the first 4 injections to be recommended for Phase 2 will be determined by reviewing the reported number of dose-limiting toxicities for weekly or bi-weekly injections.
Outcome measures
| Measure |
Phase 1: Vaccine
n=12 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Frequency of gp96 Heat Shock Protein-peptide Complex Vaccine (Phase 1)
|
2 weeks between doses
|
PRIMARY outcome
Timeframe: Up to 4 weeksSystemic toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Dose-limiting toxicity is defined as any of the following that are attributable to vaccine therapy: Any grade 3, 4 or 5 toxicity, Any grade \>=2 clinical autoimmunity with the potential to threaten critical organs (including lungs, heart, kidney, bowel, bone marrow, liver or central nervous system (CNS), or eyes), and any removal of a patient from therapy due to toxicity
Outcome measures
| Measure |
Phase 1: Vaccine
n=12 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Number of Participants With Dose Limiting Toxicities (Phase 1)
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Phase 1: Vaccine
n=41 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Median Progression-free Survival at 6 Months (Phase 2)
|
19.1 weeks
Interval 14.1 to 24.1
|
PRIMARY outcome
Timeframe: Up to 12 monthsDefined as the percentage of participants with confirmed response and who have not progressed from date of surgical resection until death or censored at 12 months
Outcome measures
| Measure |
Phase 1: Vaccine
n=41 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Percentage of Participants With Progression-free Survival at 12 Months (Phase 2)
|
29.3 percentage of participants
Interval 16.6 to 45.7
|
SECONDARY outcome
Timeframe: Up to 12 monthsAn immunological response is defined as an absolute lymphocyte count (ALC) less than the lower limit of normal (1.0 × 109cells/L), according to the standard laboratory reference range
Outcome measures
| Measure |
Phase 1: Vaccine
n=12 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Number of Patients With an Immunological Response (Phase 1)
|
11 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsAn immunological response is defined as an absolute lymphocyte count (ALC) less than the lower limit of normal (1.0 × 109cells/L), according to the standard laboratory reference range
Outcome measures
| Measure |
Phase 1: Vaccine
n=41 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Number of Patients With an Immunological Response (Phase 2)
|
27 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsVaccine treatment-related Adverse Events with a grade \>=3 according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 will be reported.
Outcome measures
| Measure |
Phase 1: Vaccine
n=41 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Number of Participants With Grade 3 or Higher, Vaccine Treatment-Related Adverse Events by Toxicity (Phase 2)
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall survival is defined as the length of time from date of surgical resection until death or censored at end of study period
Outcome measures
| Measure |
Phase 1: Vaccine
n=38 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Median Overall Survival (Phase 2)
|
42.6 weeks
Interval 34.7 to 50.5
|
SECONDARY outcome
Timeframe: Up to 6 monthsDefined as the percentage of participants still alive from date of surgical resection until death or censored at 6 months
Outcome measures
| Measure |
Phase 1: Vaccine
n=38 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Percentage of Participants Surviving at 6 Months (Phase 2)
|
90.2 percentage of participants
Interval 75.9 to 96.8
|
SECONDARY outcome
Timeframe: Up to 12 monthsDefined as the percentage of participants still alive from date of surgical resection until death or censored at 12 months
Outcome measures
| Measure |
Phase 1: Vaccine
n=38 Participants
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections
|
|---|---|
|
Percentage of Participants Surviving at 12 Months (Phase 2)
|
29.3 percentage of participants
Interval 16.6 to 45.7
|
Adverse Events
Phase 1: Vaccine
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase 2: Vaccine
Serious events: 8 serious events
Other events: 41 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Phase 1: Vaccine
n=12 participants at risk
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
|
Phase 2: Vaccine
n=41 participants at risk
Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Infections and infestations
Wound
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Infections and infestations
Skin Infection (Cellulitis)
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, Appendix
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Up to 2 years
|
Other adverse events
| Measure |
Phase 1: Vaccine
n=12 participants at risk
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
|
Phase 2: Vaccine
n=41 participants at risk
Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
|
|---|---|---|
|
Vascular disorders
Vascular
|
0.00%
0/12 • Up to 2 years
|
7.3%
3/41 • Number of events 41 • Up to 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/12 • Up to 2 years
|
7.3%
3/41 • Number of events 3 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Cerebrospinal fluid leak
|
0.00%
0/12 • Up to 2 years
|
2.4%
1/41 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
16.7%
2/12 • Number of events 3 • Up to 2 years
|
14.6%
6/41 • Number of events 6 • Up to 2 years
|
|
Nervous system disorders
Seizure
|
33.3%
4/12 • Number of events 9 • Up to 2 years
|
14.6%
6/41 • Number of events 6 • Up to 2 years
|
|
Psychiatric disorders
Mood
|
8.3%
1/12 • Number of events 1 • Up to 2 years
|
17.1%
7/41 • Number of events 7 • Up to 2 years
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/12 • Up to 2 years
|
7.3%
3/41 • Number of events 3 • Up to 2 years
|
|
Investigations
Focal deficit
|
0.00%
0/12 • Up to 2 years
|
68.3%
28/41 • Number of events 28 • Up to 2 years
|
|
General disorders
Cognitive
|
16.7%
2/12 • Number of events 2 • Up to 2 years
|
48.8%
20/41 • Number of events 20 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
41.7%
5/12 • Number of events 8 • Up to 2 years
|
22.0%
9/41 • Number of events 9 • Up to 2 years
|
|
Metabolism and nutrition disorders
Metabolic
|
75.0%
9/12 • Number of events 32 • Up to 2 years
|
39.0%
16/41 • Number of events 16 • Up to 2 years
|
|
Blood and lymphatic system disorders
Lymphatic
|
16.7%
2/12 • Number of events 2 • Up to 2 years
|
12.2%
5/41 • Number of events 5 • Up to 2 years
|
|
Infections and infestations
Infection
|
8.3%
1/12 • Number of events 1 • Up to 2 years
|
26.8%
11/41 • Number of events 11 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
4/12 • Number of events 9 • Up to 2 years
|
24.4%
10/41 • Number of events 10 • Up to 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/12 • Up to 2 years
|
7.3%
3/41 • Number of events 3 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/12 • Up to 2 years
|
12.2%
5/41 • Number of events 5 • Up to 2 years
|
|
Renal and urinary disorders
Genitourinary/renal
|
16.7%
2/12 • Number of events 2 • Up to 2 years
|
19.5%
8/41 • Number of events 8 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal
|
33.3%
4/12 • Number of events 12 • Up to 2 years
|
34.1%
14/41 • Number of events 14 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Up to 2 years
|
9.8%
4/41 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • Up to 2 years
|
12.2%
5/41 • Number of events 5 • Up to 2 years
|
|
Investigations
Injection site reaction
|
50.0%
6/12 • Number of events 9 • Up to 2 years
|
41.5%
17/41 • Number of events 17 • Up to 2 years
|
|
General disorders
Fever
|
0.00%
0/12 • Up to 2 years
|
9.8%
4/41 • Number of events 4 • Up to 2 years
|
|
General disorders
Fatigue
|
58.3%
7/12 • Number of events 10 • Up to 2 years
|
29.3%
12/41 • Number of events 12 • Up to 2 years
|
|
General disorders
Anorexia
|
8.3%
1/12 • Number of events 2 • Up to 2 years
|
9.8%
4/41 • Number of events 4 • Up to 2 years
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
8.3%
1/12 • Number of events 1 • Up to 2 years
|
0.00%
0/41 • Up to 2 years
|
|
Eye disorders
Ocular/Visual - Other
|
8.3%
1/12 • Number of events 1 • Up to 2 years
|
0.00%
0/41 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place