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Status:

ACTIVE_NOT_RECRUITING

Dinaciclib in Treating Patients With Stage IV Melanoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Acral Lentiginous Melanoma

Cutaneous Nodular Melanoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 enzyme...

Detailed 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 surviva...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 19 2026

    Estimated Enrollment :

    72 Patients enrolled

    Trial Details

    Trial ID

    NCT00937937

    Start Date

    July 1 2009

    End Date

    March 19 2026

    Last Update

    September 12 2025

    Active Locations (190)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 48 (190 locations)

    1

    Providence Hospital

    Mobile, Alabama, United States, 36608

    2

    Mercy Hospital Fort Smith

    Fort Smith, Arkansas, United States, 72903

    3

    University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    4

    Highlands Oncology Group - Rogers

    Rogers, Arkansas, United States, 72758