Clinical trial · Interventional
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma
Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSPPC-96 | Biological | — | UNRESOLVED |
| Standard Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1: Vaccine
- description
- Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
- interventionNames
- Biological: HSPPC-96
- Procedure: Standard Surgical Resection
- type
- EXPERIMENTAL
- label
- Phase 2: Vaccine
- description
- 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.
- interventionNames
- Biological: HSPPC-96
- Procedure: Standard Surgical Resection
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 weeksReferences
Publications (2)
- BACKGROUNDCrane CA, Han SJ, Ahn B, Oehlke J, Kivett V, Fedoroff A, Butowski N, Chang SM, Clarke J, Berger MS, McDermott MW, Prados MD, Parsa AT. Individual patient-specific immunity against high-grade glioma after vaccination with autologous tumor derived peptides bound to the 96 KD chaperone protein. Clin Cancer Res. 2013 Jan 1;19(1):205-14. doi: 10.1158/1078-0432.CCR-11-3358. Epub 2012 Aug 7. PMID 22872572
- RESULTBloch O, Crane CA, Fuks Y, Kaur R, Aghi MK, Berger MS, Butowski NA, Chang SM, Clarke JL, McDermott MW, Prados MD, Sloan AE, Bruce JN, Parsa AT. Heat-shock protein peptide complex-96 vaccination for recurrent glioblastoma: a phase II, single-arm trial. Neuro Oncol. 2014 Jan;16(2):274-9. doi: 10.1093/neuonc/not203. Epub 2013 Dec 12. PMID 24335700