Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Determine the Overall Objective Response Rate (CR and PR).
研究概览
简要总结
Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients.
One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves.
In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage.
We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary.
- •Histologic proof of melanoma reviewed and confirmed at MSKCC
- •Measurable disease (RECIST criteria)
- •No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed.
- •No other concurrent chemotherapy, immunotherapy, or radiotherapy
- •Karnofsky performance status ≥ 60
- •Adequate organ function defined as follows: ANC > 1500, Platelets > 100,000, creatinine < 2, Alkaline Phosphatase, AST and total bilirubin < 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement.
- •Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node).
排除标准
- •History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months.
- •Uveal or mucosal melanoma primary
- •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
1 - Temozolomide (TMZ)
干预措施: Temozolomide (TMZ) (Drug)
结局指标
主要结局
Determine the Overall Objective Response Rate (CR and PR).
时间窗: From start of treatment through 24 weeks after ending treatment
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
- Duration of Objective Clinical Responses(24 weeks after ending treatment)
- Overall Survival(18 months after ending treatment)