PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response rate (complete response [CR] and partial response [PR]}
研究概览
简要总结
This phase II trial is studying how well tipifarnib works in treating patients with metastatic malignant melanoma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the clinical response rate in patients with metastatic malignant melanoma treated with R115777 (tipifarnib).
II. To evaluate the safety of R115777 in patients with metastatic melanoma.
SECONDARY OBJECTIVES:
I. To assess RhoC expression in tumor samples pre- and post- therapy with R115777.
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
- •Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
- •Patients must have at least 2 cutaneous lesions amenable to excisional biopsy for correlative studies; in addition, patients must have measurable disease; the disease remaining after the first excisional biopsy must be measurable; lesions that are considered intrinsically non-measurable include the following:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •Lesions that are situated in a previously irradiated area
- •No history of brain metastases
- •No allergies to azoles (e.g. ketoconazole) or allergies to compounds structurally similar to R115777
- •No more than 1 prior immunotherapy regimen for treatment of advanced melanoma; an additional immunologic therapy in the adjuvant setting (e.g. IFN-a) is acceptable; prior chemotherapy for any stage of melanoma is not allowed
- •No radiotherapy or immunotherapy within four weeks prior to the initiation of therapy on this study
- •CTC (ECOG) performance status 0-1
- •Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control; women of child-bearing age will undergo pregnancy testing
- •ANC >= 1500/uL
- •Platelets >= 100,000/uL
- •Bilirubin =< 1.5 mg/dL
- •Creatinine =< 2.0 mg/dL
排除标准
- 未提供
研究组 & 干预措施
Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity. Patients who achieve CR receive 2 additional courses beyond CR.
干预措施: tipifarnib (Drug)
Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity. Patients who achieve CR receive 2 additional courses beyond CR.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate (complete response [CR] and partial response [PR]}
时间窗: Up to 2 years
Estimated confidence intervals will be adjusted for the number of stages.
Progression-free survival (PFS)
时间窗: From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years
Estimated using the method of Kaplan and Meier.
Time to treatment failure (TTF)
时间窗: From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years
Estimated using the method of Kaplan and Meier.
次要结局
- Correlation between RhoC expression levels and response(From baseline to up to 2 years)
- Change in FTAse levels(From baseline to up to 2 years)
- Change in the production of IL-2 and IFN-g by T cells(From baseline to up to 2 years)
- Adverse events as assessed by Common Toxicity Criteria (CTC) version 2.0(Up to 2 years)