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RATIONALE: Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of dinaciclib and to see how well it works in treating patients with stage III or stage IV malignant melanoma that cannot be removed by surgery.
- To determine the recommended phase II dose of dinaciclib administered as a 4-hour infusion every other week in patients with advanced malignant melanoma. (Phase I)
- To determine the 1-year overall survival of patients treated with dinaciclib at the dose and schedule derived in the phase I part of the study. (Phase II)
- To characterize the safety profile and toxicities of dinaciclib.
- To determine the pharmacokinetics of dinaciclib.
- To determine the 6-month progression-free survival rate in patients treated with this drug. (Phase II)
- To determine the objective response rate in patients treated with this drug. (Phase II)
- To document cdk2, cdk2/1, and cdk9 inhibition in surrogate tissues and tumor.
- To correlate the degree of change of pharmacodynamic parameters in pre- and post-treatment samples with clinical outcome.
- To correlate the degree of change of parameters defining cdk2, cdk2/1, and cdk9 inhibition with pharmacokinetic parameters.
- To correlate pre-treatment cdk2 levels with the degree of change of parameters measuring cdk2 inhibition.
- To correlate pre-treatment cdk2 levels with clinical outcome.
- To correlate tumor p53 status with clinical outcome.
OUTLINE: This is a multicenter study.
Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected periodically for pharmacokinetics and other correlative laboratory studies.
After completion of study treatment, patients are followed every 3 months.
Masking: Open Label, Primary Purpose: Treatment
dinaciclib, laboratory biomarker analysis, pharmacological study
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:11:32-0400
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