Phase 2
Completed N=96
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma
Source: ClinicalTrials.gov NCT00293423 ↗Enrolled (actual)
96
Serious AEs
15.1%
Results posted
May 2021
Primary outcomePrimary: Maximum Tolerated Dose (MTD) (Phase 1) — 25 micrograms
Summary
Vaccines made from a person's tumor cells, such as gp96 heat shock protein-peptide complex, may help the body build an effective immune response to kill tumor cells. This phase I/II trial is studying the side effects and best dose of gp96 heat shock protein-peptide complex vaccine to see how well it works in treating patients with recurrent or progressive high-grade glioma over time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) (Phase 1) |
25 | — |
| PRIMARY Frequency of gp96 Heat Shock Protein-peptide Complex Vaccine (Phase 1) |
2 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (Phase 1) |
— | — |
| PRIMARY Median Progression-free Survival at 6 Months (Phase 2) |
19.1 | — |
| PRIMARY Percentage of Participants With Progression-free Survival at 12 Months (Phase 2) |
29.3 | — |
| SECONDARY Number of Patients With an Immunological Response (Phase 1) |
11 | — |
| SECONDARY Number of Patients With an Immunological Response (Phase 2) |
27 | — |
| SECONDARY Number of Participants With Grade 3 or Higher, Vaccine Treatment-Related Adverse Events by Toxicity (Phase 2) |
1 | — |
| SECONDARY Median Overall Survival (Phase 2) |
42.6 | — |
| SECONDARY Percentage of Participants Surviving at 6 Months (Phase 2) |
90.2 | — |
| SECONDARY Percentage of Participants Surviving at 12 Months (Phase 2) |
29.3 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant recurrent glioma*, including any of the following:
- Glioblastoma
- Glioblastoma multiforme
- Recurrent disease or progressive primary disease
- Surgically accessible tumor for which surgical resection is indicated and has not been previously irradiated
- Prior radiotherapy required
- No prior oncophage therapy or immunotherapy for glioma
PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Life expectancy ≥ 8 weeks
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Alkaline phosphatase and serum glutamic-pyruvic transaminase (SGPT) <=2.5 times normal
- Bilirubin < 1.5 mg/dL
- Blood Urea Nitrogen (BUN) < 1.5 times normal OR creatinine < 1.5 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for at least 4 weeks after completion of study treatment
- No uncontrolled active infection
- No bleeding diathesis
- No psychiatric or medical situation that would preclude study compliance
- No unstable or severe concurrent medical condition
- No other cancer or concurrent malignancy within the past 5 years except adequately treated nonmetastatic in situ carcinoma of the uterine cervix, nonmetastatic nonmelanoma skin cancer, or in complete remission and off all therapy for that disease
- No systemic autoimmune disease (e.g., Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 weeks since prior vincristine
- At least 6 weeks since prior nitrosoureas
- At least 4 weeks since prior temozolomide or other cytotoxic chemotherapy
- At least 4 weeks since prior investigational agents
- At least 1 week since prior noncytotoxic agents
- At least 3 weeks since prior procarbazine
- No radiotherapy within the past 4 weeks
Data sourced from ClinicalTrials.gov (NCT00293423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.