Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrent astrocytoma or oligodendroglioma.
详细描述
OBJECTIVES:
- Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and adoptive immunotherapy, in terms of time to progression and median and one-year survival, in patients with primary or recurrent malignant astrocytoma or oligodendroglioma.
- Determine the immunogenicity of malignant gliomas in patients treated with this regimen.
OUTLINE: Patients are stratified according to extent of disease, extent of antigen-specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo tumor resection on week 1. Patients without recurrent disease receive local radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may receive up to 3 additional vaccinations every 2 weeks until a response is detected.
Patients undergo peripheral blood mononuclear cell collection on week 14 followed by monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16. Treatment continues in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 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 proven grade II, III, or IV astrocytoma or oligodendroglioma
- •Evidence of primary or recurrent tumor by MRI
- •Resectable disease
- •At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •SWOG 0 or 1
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least lower limit of normal
- •No active or recent uncontrolled bleeding
- •Bilirubin normal
- •SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Creatinine normal
- •Able to be weaned off steroids
- •Negative stool guaiac
- •No impaired immunity
- •No uncontrolled diabetes
- •No active uncontrolled infections
- •No other serious disease
- •No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •No psychological, familial, sociological, or geographical conditions that would preclude compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No concurrent chemotherapy except for progressive disease
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •Radium implants allowed
- •Not specified
- •At least 1 week since prior therapy and recovered
排除标准
- 未提供