GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma

NCT00293423 | Completed Phase 1 Results DMC FDA Drug

• 5 other identifiers: 05103UCSF-H41995-27311-01NCI-2011-01231P50CA097257-06R01CA164714-02
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; recurrent adult brain tumor

Outcome Measures

Primary Outcomes (5)

• Maximum Tolerated Dose (MTD) (Phase 1)

  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

  Up to 4 weeks

• Frequency of gp96 Heat Shock Protein-peptide Complex Vaccine (Phase 1)

  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.

  Up to 6 months

• Number of Participants With Dose Limiting Toxicities (Phase 1)

  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

  Up to 4 weeks

• Median Progression-free Survival at 6 Months (Phase 2)

  6 months

• Percentage of Participants With Progression-free Survival at 12 Months (Phase 2)

  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

  Up to 12 months

Secondary Outcomes (6)

• Number of Patients With an Immunological Response (Phase 1)

  Up to 12 months

• Number of Patients With an Immunological Response (Phase 2)

  Up to 2 years

• Number of Participants With Grade 3 or Higher, Vaccine Treatment-Related Adverse Events by Toxicity (Phase 2)

  Up to 2 years

• Median Overall Survival (Phase 2)

  Up to 2 years

• Percentage of Participants Surviving at 6 Months (Phase 2)

  Up to 6 months

Study Arms (2)

Phase 1: Vaccine

EXPERIMENTAL

Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.

Biological: HSPPC-96; Procedure: Standard Surgical Resection

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.

Biological: HSPPC-96; Procedure: Standard Surgical Resection

Interventions

HSPPC-96 BIOLOGICAL

25 mcg

Also known as: Heat Shock, Glycoprotein 96, Gp96

Phase 1: Vaccine; Phase 2: Vaccine

Standard Surgical Resection PROCEDURE

Patients will undergo standard surgical resection of intracranial tumor

Also known as: Craniotomy

Phase 1: Vaccine; Phase 2: Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator
• Agenus Inc.: collaborator
• American Brain Tumor Association: collaborator

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• Crane 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 BACKGROUND

• Bloch 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 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Brain Neoplasms

Interventions

vitespin; Heat-Shock Response; myelin oligodendrocyte glycoprotein (74-96), human; glucose-regulated proteins; Craniotomy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Stress, Physiological; Physiological Phenomena; Neurosurgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Orin Bloch
• Organization: University of California, Davis

obloch@ucdavis.edu

Study Officials

• Jennifer Clarke, MD

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: November 18, 2005
• Primary Completion: January 12, 2013
• Study Completion: January 12, 2013
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)