Dinaciclib in Treating Patients With Stage IV Melanoma
Condition: Acral Lentiginous Melanoma; Cutaneous Nodular Melanoma; Lentigo Maligna Melanoma; Low-CSD Melanoma; Mucosal Melanoma; Recurrent Melanoma; Stage IV Cutaneous Melanoma AJCC v6 and v7
MeSH terms: Melanoma; Hutchinson's Melanotic Freckle; Lentigo
Intervention: Dinaciclib
Intervention description: Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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