Dinaciclib in Treating Patients With Stage III-IV Melanoma

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 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 advanced melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclin-Dependent Kinase Inhibitor Proteins

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed, unresectable stage III or stage IV malignant melanoma

• ECOG performance status =< 1

• Absolute neutrophil count >= 1.5 x 10^9/L

• Platelets >= 100 x 10^9/L

• Total bilirubin within normal institutional limits

• AST(SGOT)/ALT(SGPT =< 1.5 x institutional upper limit of normal

• Creatinine =< 1.5 mg/dl OR

• Creatinine clearance >= 50 mL/min for patients with creatinine levels above institutional normal

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Eligible patients must agree to pre- and post-treatment biopsies of normal skin; in the phase 1 part of the study, patients with cutaneous disease or accessible lymph nodes must also agree to pre- and post-treatment tumor biopsies; in the phase 2 part of the study, tumor biopsies are required of the first 20 patients enrolled who have cutaneous disease or accessible lymph nodes

• Patients enrolled to the Phase 2 portion of the study must have measurable disease by RECIST criteria

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier

• Patients may not be receiving any other investigational agents

• Patients with active CNS metastases are excluded; patients with a history of CNS metastases that have been treated must be stable for 4 weeks after completion of treatment, with image documentation required; patients must not be taking enzyme-inducing anticonvulsants and must be either off steroids or be receiving a stable dose of steroids

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with SCH727965

• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SCH727965; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

• Patients with other currently active malignancies are excluded, except those with an in-situ cancer or basal or squamous cell carcinoma of the skin

• In the phase 2 part of the study, patients who have received prior investigational treatment with a cdk inhibitor are excluded