Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00905060 | HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM | PHASE2 | COMPLETED | 70 | — | — | Jun 29, 2009 | Jun 3, 2014 | Mar 24, 2021 | 9 | United States |
| NCT00293423 | GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma | PHASE1 | COMPLETED | 96 | — | — | Nov 18, 2005 | Jan 12, 2013 | May 13, 2021 | 3 | United States |
Overall survival is defined as the time from surgical resection to death of any cause.
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
The 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.
Systemic 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
Defined 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
| Arm | Type | Description |
|---|---|---|
| Protein Peptide-Complex (HSPPC-96) | EXPERIMENTAL | Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression. |
| Phase 1: Vaccine | EXPERIMENTAL | Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections. |
| Phase 2: Vaccine | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| HSPPC-96 | BIOLOGICAL | Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide. |
| Temozolomide | DRUG | Maintenance temozolomide treatment is given 2 weeks after administration of the fourth vaccine at an initial dose of 150 mg per square meter (mg/m2) for 5 consecutive days in a 28-day cycle. The dose was increased to 200 mg/m2 for 5 days in subsequent cycles. |
| Standard Surgical Resection | PROCEDURE | Patients will undergo standard surgical resection of intracranial tumor |
Inclusion Criteria: Pre-surgery tissue acquisition Inclusion criteria 1. Age \> or equal to 18 years old 2. Life expectancy of greater than 12 weeks. 3. Able to read and understand the informed consent document; must sign the informed consent 4. Must have suspected diagnosis of Glioblastoma Multif...