Dinaciclib in Treating Patients With Stage III-IV Melanoma

Stopped early · Phase 1/Phase 2

Conditions studied: Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

In brief

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.

Key facts

Study ID: NCT01026324
Run by: National Cancer Institute (NCI)
People needed: 12
Starts: 2009-09-01
Expected to finish: 2014-10-01
Last updated by the study team: 2017-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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