Overview

This trial is active, not recruiting.

Conditions acral lentiginous malignant melanoma, lentigo maligna malignant melanoma, mucosal melanoma, nodular malignant melanoma, recurrent melanoma, stage iv melanoma, superficial spreading malignant melanoma
Treatment dinaciclib
Phase phase 2
Targets CDK4, CDK1, CDK2, CDK5, CDK9
Sponsor National Cancer Institute (NCI)
Start date July 2009
End date October 2013
Trial size 55 participants
Trial identifier NCT00937937, CDR0000647155, NCI-2011-01935, S0826, SWOG-S0826, U10CA032102

Summary

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
dinaciclib CDK inhibitor SCH 727965
Given IV

Primary Outcomes

Measure
Overall survival
time frame: 1 year

Secondary Outcomes

Measure
Progression-free survival assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
time frame: 6 months
Response rate (confirmed and unconfirmed complete and partial responses) assessed by RECIST
time frame: Up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Biopsy-confirmed malignant melanoma - Stage IV disease - Cutaneous or mucosal origin - Melanoma of unknown primary allowed - No ocular melanoma - Measurable or non-measurable disease - No prior or concurrent brain metastases as confirmed by CT scan or MRI - Zubrod performance status 0-1 - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL - Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases) - SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases) - Serum creatinine ≤ 1.5 times ULN - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy except for 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 - No prior therapy with a cyclin-dependent kinase inhibitor - At least 14 days since prior radiotherapy - At least 28 days since prior systemic chemotherapy - At least 28 days since prior adjuvant systemic therapy - At least 28 days since prior surgery - No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1 - Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy - Therapy for stage IV resected free-of-disease will be considered adjuvant therapy - Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1 - Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1 - No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy) - No concurrent CYP3A4 inhibitors or inducers - No concurrent grapefruit or grapefruit juice

Additional Information

Official title A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
Principal investigator Christopher Lao
Description PRIMARY OBJECTIVES: I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib. SECONDARY OBJECTIVES: I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease. III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma. OUTLINE: This is a multicenter study. Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).