NCT00278122暂停2 期
Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Clinical response by CT scans every 6 weeks
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in treating melanoma.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Assess the activity of paclitaxel and sargramostim (GM-CSF), in terms of objective clinical response rate (complete response [CR] and partial response [PR]), in patients with advanced unresectable melanoma.
Secondary
- Evaluate the duration of response, time to progression, and overall survival of patients treated with this regimen.
- Determine serum cytokine levels (GM-CSF, IFN-γ, aldesleukin, recombinant interleukin-4, and IL-10) 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
- 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 unresectable stage III or IV melanoma from a cutaneous, mucosal, or unknown primary site
- •Unresectable stage III disease, defined as meeting 1 of the following criteria:
- •Regional metastasis that, in the judgement of the treating physician, cannot be surgically resected with clear margins
- •Regional metastasis that can be surgically resected with clear margins only by extensive surgery that is inadvisable or unacceptable to the treating physician and/or patient
- •Staging of cutaneous and mucosal melanoma based on the revised American Joint Committee on Cancer (AJCC) staging system
- •Must have measurable disease as defined by Response Evaluation Criteria in Small Tumors (RECIST) criteria
- •No ocular melanoma
- •Patients with brain metastases may be eligible if all of the following are true:
- •Total number of brain metastases ever is ≤ 3
- •Each brain metastasis has been completely removed by surgery or each unresected brain metastasis has been treated with stereotactic radiosurgery
- •Stereotactic radiosurgery, such as gamma knife, can be used up to 1 week before study entry
- •No evident growth of any brain metastasis since treatment
- •No brain metastasis that is > 2 cm in diameter at study entry
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 9 g/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Bilirubin normal
- •Creatinine ≤ 1.5 times ULN
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No previous or concurrent autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- •No autoimmune disorder with visceral involvement
- •The following conditions are allowed:
- •Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
- •Clinical evidence of vitiligo
- •Other forms of depigmenting illness
- •Mild arthritis requiring steroidal anti-inflammatory drugs
- •HIV negative
- •Hepatitis C negative
- •No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy
- •PRIOR CONCURRENT THERAPY:
- •No more than 1 previous chemotherapy regimen for metastatic melanoma
- •No previous paclitaxel
- •No chemotherapy, interferon, growth factors, interleukin, or radiotherapy (excluding gamma knife therapy for brain metastases) within the past 4 weeks
- •No surgical resection of metastatic lesions within the past 4 weeks
- •No other investigational medication within the past 4 weeks or during study
- •No nitrosoureas (e.g., carmustine or lomustine) within the past 6 weeks and during study treatment
- •No other concurrent chemotherapy, interferon, other growth factors, interleukin, illegal drugs, radiotherapy, surgery, or steroid therapy
- •No concurrent oral or injectable hydrocortisone (at doses > 15 mg per day) or its equivalent
排除标准
- 未提供
结局指标
主要结局
Clinical response by CT scans every 6 weeks
次要结局
- Survival
- Duration of response by CT scans every 6 weeks
- Time to progression by CT scans every 6 weeks
研究者
研究点 (1)
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