Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose at completion of study
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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastatic melanoma.
详细描述
OBJECTIVES:
- Determine the safety of interleukin-12-primed activated T cells (12ATC) and temozolomide in patients with metastatic melanoma.
- Determine the maximum tolerated dose of 12ATC in this patient population.
- Determine the clinical response of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC).
Patients undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells (PBMC) are obtained. The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3, interleukin-2, and interleukin-12 to form 12ATC.
Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22, 25, 29, 32, 36, 39, 50, 53, 57, 60, 64, and 67 in the absence of disease progression or unacceptable toxicity.
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 cytologically confirmed metastatic melanoma
- •No ocular or mucosal melanoma
- •Must meet one of the following criteria:
- •Failed standard or salvage therapy
- •Ineligible for standard therapy due to concurrent illness
- •Declined standard therapy
- •Received at least 1 prior therapy for metastatic disease
- •Brain metastasis as only site of metastatic disease allowed if there is documented evidence of progression after at least 1 prior treatment for metastases
- •No leptomeningeal metastases
- •At least 1 documented site of bidimensionally measurable disease by MRI or CT scan
- •Previously irradiated lesions not considered measurable unless documented disease progression after radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •No coagulation disorder such as thrombophlebitis
- •Bilirubin less than 2.0 mg/dL
- •AST and ALT less than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 3 times ULN
- •Creatinine less than 1.5 times ULN
- •BUN less than 1.5 times ULN
- •Cardiovascular:
- •Ejection fraction at least 45%
- •No active ischemia
- •No unstable angina
- •No uncontrolled congestive heart failure
- •Normal pulmonary function tests within the past month
- •FEV1 or FVC more than 65% predicted
- •No uncontrolled pulmonary embolism
- •Gastrointestinal:
- •No frequent vomiting
- •No medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
- •No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3 weeks
- •No uncontrolled cortical dysfunction
- •No other major medical illness (e.g., active systemic infection, autoimmune disease, or uncontrolled thyroid abnormality)
- •No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix
- •No significant psychiatric disease that would preclude study compliance
- •No AIDS-related illness
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- 另有 12 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose at completion of study
Safety as measured by NCI common toxicity table at completion of study
次要结局
未报告次要终点