Dinaciclib in Treating Patients With Stage IV Melanoma

Running, not enrolling · Phase 2

Conditions studied: Acral Lentiginous Melanoma, Cutaneous Nodular Melanoma, Lentigo Maligna Melanoma, Low-CSD Melanoma, Mucosal Melanoma, Recurrent Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7

In brief

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.

Key facts

Study ID

NCT00937937

Run by

National Cancer Institute (NCI)

People needed

72

Starts

2009-07-01

Expected to finish

2027-03-19

Last updated by the study team

2026-05-29

Who can join

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

You may qualify if…

• 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

Where it is running

• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Highlands Oncology Group - Rogers — Rogers, Arkansas, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• El Camino Hospital — Mountain View, California, United States
• Wilma Chan Highland Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Hematology and Oncology Associates-Oakland — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• Doctors Medical Center- JC Robinson Regional Cancer Center — San Pablo, California, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Boca Raton Comprehensive Cancer Center — Boca Raton, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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