Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Response rate as measured scans and tumor measurements every 8 weeks
研究概览
简要总结
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.
详细描述
OBJECTIVES:
- Determine the response rate in patients with recurrent or metastatic malignant melanoma treated with PEG-interferon alfa-2b and thalidomide.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.
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 confirmed malignant melanoma, including any of the following:
- •Cutaneous melanoma
- •Ocular melanoma
- •Mucosal melanoma
- •Unidentified primary tumor
- •Recurrent or metastatic disease
- •Bidimensionally measurable or evaluable disease
- •Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •SGOT ≤ 2 times ULN
- •Creatinine ≤ 2 mg/dL
- •Cardiovascular
- •None of the following conditions within the past 3 months:
- •Congestive heart failure
- •Second- or third-degree heart block
- •Myocardial infarction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
- •No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
- •No concurrent blood, sperm, or ova donation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior biologic therapy (e.g., interferon) allowed
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 28 days since prior radiotherapy
- •At least 28 days since prior surgery
- •No more than 2 prior systemic treatment regimens for metastatic malignant melanoma
排除标准
- 未提供
结局指标
主要结局
Response rate as measured scans and tumor measurements every 8 weeks
Qualitative and quantitative toxicities at 30 days following study treatment
次要结局
- Progression-free survival by standard life table and Kaplan-Meier
- Overall survival by standard life table and Kaplan-Meier
- Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks