Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
Recurrent Melanoma, Stage IV Melanoma

About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: 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 Ascites 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
Sites / Locations
- Cancer and Leukemia Group B
Arms of the Study
Arm 1
Experimental
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.