Dinaciclib in Treating Patients With Stage IV Melanoma

National Cancer Institute (NCI)

Status and phase

Active, not recruiting

Phase 2

Conditions

Mucosal Melanoma

Stage IV Cutaneous Melanoma AJCC v6 and v7

Lentigo Maligna Melanoma

Low-CSD Melanoma

Recurrent Melanoma

Cutaneous Nodular Melanoma

Acral Lentiginous Melanoma

Treatments

Drug: Dinaciclib

Study type

Interventional

Funder types

NIH

Identifiers

NCT00937937

NCI-2011-01935 (Registry Identifier)

S0826 (Other Identifier)

SWOG-S0826

U10CA032102 (U.S. NIH Grant/Contract)

CDR0000647155

Details and patient eligibility

About

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.

Full description

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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