Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Frequency of gp96 Heat Shock Protein-peptide Complex Vaccine (Phase 1)
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
- Phase 1: [closed to accrual as of 7/25/2007]: Determine the safety and best tolerated dose and frequency of gp96 heat shock protein-peptide complex vaccine in patients with recurrent or progressive high-grade glioma.
- Phase 2: Determine the clinical response to treatment, time to disease recurrence and progression, and overall survival of patients treated with this vaccine.
SECONDARY OBJECTIVES:
- Determine the immune response in patients treated with this vaccine.
- Determine survival outcomes in patients treated with this vaccine.
OUTLINE: This is a dose-escalation, phase I study (closed to accrual as of 7/25/2007) followed by a phase II study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Phase 1: Vaccine
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
干预措施: Standard Surgical Resection (Procedure)
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.
干预措施: Standard Surgical Resection (Procedure)
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.
干预措施: HSPPC-96 (Biological)
Phase 1: Vaccine
Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
干预措施: HSPPC-96 (Biological)
结局指标
主要结局
Frequency of gp96 Heat Shock Protein-peptide Complex Vaccine (Phase 1)
时间窗: Up to 6 months
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.
Maximum Tolerated Dose (MTD) (Phase 1)
时间窗: Up to 4 weeks
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
Median Progression-free Survival at 6 Months (Phase 2)
时间窗: 6 months
Number of Participants With Dose Limiting Toxicities (Phase 1)
时间窗: Up to 4 weeks
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
Percentage of Participants With Progression-free Survival at 12 Months (Phase 2)
时间窗: Up to 12 months
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
次要结局
- Number of Patients With an Immunological Response (Phase 1)(Up to 12 months)
- Percentage of Participants Surviving at 12 Months (Phase 2)(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)
研究者
Orin Bloch, MD
Principal Investigator
University of California, San Francisco