Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Overall Response to CVT Chemotherapy.
研究概览
简要总结
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Histologic proof of melanoma reviewed and confirmed at MSKCC
- •Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible.
- •Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate.
- •No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed.
- •No other concurrent chemotherapy, immunotherapy, or radiotherapy
- •ECOG performance status ≤ 1
- •Adequate organ function defined as follows: ANC >1500/mm3, Platelets >130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft & Gault).
- •Adequate cardiac function to tolerate the hydration needed for cisplatin administration.
排除标准
- •History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months.
- •Uveal melanoma primary
- •Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease.
- •Frequent vomiting or medical conditions that could interfere with oral medication intake
- •Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
- •History of HIV infection even if on HAART
- •Immunosuppressive drugs
- •High dose vitamins and herbs
- •Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
研究组 & 干预措施
Chemotherapy
This is a single institution phase II trial in stage III or IV melanoma patients with measurable disease but no prior cytotoxic chemotherapy and not thought to be curable by surgery.Before starting the chemotherapy, you may need to have a fresh biopsy of your tumor. If you have already had a tumor biopsy that we can use, you may not need another biopsy. Your study doctor will review with you the biopsies you have had. We will try to obtain biopsy material that already exists but if we cannot, you will need another biopsy.
干预措施: Cisplatin, Vinblastine, Temozolomide (Drug)
结局指标
主要结局
Overall Response to CVT Chemotherapy.
时间窗: 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
未报告次要终点