Dinaciclib in Treating Patients With Stage IV Melanoma

• Status: Active, not recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

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