NCT00085579撤回2 期
A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.
详细描述
OBJECTIVES:
Primary
- Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim (GM-CSF).
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the effects of this regimen on lymphocyte subsets in these patients.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed melanoma
- •Stage III or IV disease
- •No primary ocular melanoma
- •Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago
- •Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible
- •Patients whose second evaluation shows disease progression are eligible unless one of the following is true:
- •Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN)
- •LDH > ULN AND is higher than the patient's highest value before systemic chemotherapy
- •Patient has developed a new tumor measuring > 1 cm in diameter
- •Sum of the longest diameters of the existing tumor has increased > 20%
- •Evaluable or measurable disease
- •Not potentially curable by surgery
- •No active CNS metastases
- •Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No active bleeding
- •See Disease Characteristics
- •Bilirubin ≤ 2.0 mg/dL
- •Creatinine ≤ 1.2 mg/dL
- •Cardiovascular
- •Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following:
- •Normal exercise stress test
- •Normal stress thallium test
- •Normal comparable cardiac ischemia evaluation
- •LVEF ≥ 40%
- •No active infection requiring treatment
- •No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No other concurrent antineoplastic biologic response modifier therapy
- •No concurrent antineoplastic vaccine therapy
- •Chemotherapy
- •See Disease Characteristics
- •No concurrent antineoplastic chemotherapy
- •Endocrine therapy
- •No concurrent steroidal antiemetics
- •No concurrent systemic corticosteroids
- •Radiotherapy
- 另有 7 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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