Dinaciclib in Treating Patients With Stage IV Melanoma

For people ages 18 years and up

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/mm³
• Platelet count ≥ 100,000/mm³
• 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