Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 试验地点
- 1
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. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma.
PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.
详细描述
OBJECTIVES:
- Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas.
- Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients.
OUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction.
Patients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter.
Disease restaging is done every 8-12 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma)
- •Must be a candidate for neurosurgical biopsy or tumor debulking
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance Status:
- •Karnofsky 60-100%
- •Life Expectancy:
- •Greater than 4 months
- •Hematopoietic:
- •Granulocytes greater than 1,500/mm^3
- •Platelet count greater than 50,000/mm^3
- •PT and PTT within normal limits
- •Bilirubin no greater than 1.5 times upper limit of normal
- •Creatinine less than 1.5 mg/dL
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No congestive heart failure
- •No coronary artery disease
- •No serious cardiac arrhythmias
- •No prior myocardial infarction
- •No major pulmonary problems
- •No history of neurologic disease (except related to brain tumor)
- •No psychosis
- •No impaired cognitive function
- •No significant concurrent medical illness
- •No active infection requiring antibiotic therapy
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device
- •No hepatitis B or C
- •HIV negative
- •No prior autoimmune disease
- •Allergy to gentamicin is allowed
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 6 weeks since prior immunotherapy and recovered
- •No concurrent immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Reduction or elimination of corticosteroids
- •Not greater than 0.15 mg/kg/day dexamethasone equivalent
- •Radiotherapy:
- •At least 6 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •Prior surgery is allowed
- •Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed
排除标准
- 未提供