Dinaciclib in Treating Patients With Stage III-IV Melanoma

PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose of SCH727965 administered as a 4-hour infusion every other week in patients with advanced malignant melanoma. (Phase I) II. To determine the 1-year overall survival of patients with malignant melanoma treated with SCH727965 at the dose and schedule derived in the phase 1 part of the study. (Phase II) SECONDARY OBJECTIVES: I. To characterize the safety profile and toxicities of SCH727965 administered as a 4-hour infusion every other week. II. To determine the pharmacokinetics of SCH727965 administered as a 4-hour infusion every other week. III. To determine the proportion of patients with malignant melanoma who are alive without progression of disease 6 months after beginning treatment with SCH727965 at the dose and schedule derived in the phase 1 part of the study. IV. To determine the objective response rate to SCH727965 of patients with malignant melanoma enrolled to part 2 of the study. V. To document cdk2, combined cdk2/1 and cdk9 inhibition in surrogate tissues and tumor. VI. To correlate the degree of change of pharmacodynamic parameters in post-treatment compared to pre-treatment samples with clinical outcome. VII. To correlate the degree of change of parameters defining cdk2, cdk2/1 and cdk9 inhibition with pharmacokinetic parameters. VIII. To correlate pre-treatment cdk2 levels with the degree of change of parameters measuring cdk2 inhibition. IX. To correlate pre-treatment cdk2 levels with clinical outcome. X. To correlate tumor p53 status with clinical outcome. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.