A Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma

Biopsy-proven malignant melanoma of cutaneous or mucosal origin. No ocular melanoma. Stage IV disease. Unknown primary eligible. Must be offered participation in submission and banking of tissue for future use. Measurable or non-measurable disease. No hx of brain mets. Zubrod PS 0-1. May have received up to one prior systemic regimen for Stage IV melanoma excluding prior tx with a cdk inhibitor. May have received any number of prior adjuvant therapy regimens. May have received prior RT. May have received prior surgery. Side effects from any prior treatment must have resolved to </= Grade 1. Must not be pregnant or nursing. Must not be receiving or planning to receive any non-protocol treatment. No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. Within 28 days prior to reg: assessment of measurable disease; ANC >/= 1,500/mcl; platelets >/=100,000/mcl; hemoglobin >/= 9 gm/dl; serum bilirubin </= 1.5xIULN; SGOT or SGPT </= 2.5xIULN (or </= 5xIULN if liver mets); serum creatinine </= 1.5xIULN. Within 42 days prior to reg: assessment of non-measurable disease; brain scan.