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ACTIVE NOT RECRUITING

NCT00937937

PHASE2

Dinaciclib in Treating Patients With Stage IV Melanoma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2009-07-01

Completion Date

2027-03-19

Last Updated

2026-09-14

Healthy Volunteers

Conditions

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

Interventions

DRUG

Dinaciclib

Given IV

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

Locations (190)

Providence Hospital

Mobile, Alabama, United States

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