Dinaciclib in Treating Patients With Stage IV Melanoma

PRIMARY OBJECTIVES:

I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with
dinaciclib.

SECONDARY OBJECTIVES:

I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate
the response rate (confirmed and unconfirmed complete and partial responses) in the subset of
patients with measurable disease.

III. To assess the safety and tolerability of dinaciclib given to patients with stage IV
melanoma.

OUTLINE: This is a multicenter study.

Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 3
years.

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