Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.
详细描述
OBJECTIVES:
- Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.
- Determine the safety and tolerability of this regimen in this patient population.
- Determine the changes in quality of life over time in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.
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 confirmed unresectable stage IV melanoma
- •Measurable metastatic disease
- •No uncontrolled brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT and SGPT no greater than 3 times ULN
- •Alkaline phosphatase no greater than 3 times ULN
- •BUN no greater than 1.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No significant cardiovascular disease
- •No non-malignant systemic disease
- •No acute infection requiring IV antibiotics
- •No alcohol or substance abuse
- •No other condition, disease, or history of other illness that would preclude study participation
- •No hypersensitivity, allergic reactions, or intolerance to study drugs
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •No prior interleukin-2
- •No other concurrent immunotherapy
- •No concurrent investigational vaccines or immunomodulatory agents
- •No other concurrent growth factors
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •No prior temozolomide
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy:
- •No concurrent steroids (including corticosteroids)
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior major surgery
- •At least 30 days since prior immune-based therapy
- •No concurrent participation in other clinical trials with investigational drugs
- •No other concurrent anticancer drugs
- •No concurrent immunosuppressive therapy
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排除标准
- 未提供