Dinaciclib in Treating Patients With Stage IV Melanoma

Overview

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 Title of Study: “A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 22, 2013

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 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.

Interventions

  • Drug: Dinaciclib
    • Given IV

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Overall Survival
    • Time Frame: Weekly, up to 3 years
    • From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Secondary Measures

  • Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
    • Time Frame: Disease assessment was performed every 6 weeks, up to 3 years.
    • Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.
  • Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST
    • Time Frame: Disease assessments for response were performed every 6 weeks, up to 3 years
    • Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
  • Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
    • Time Frame: Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
    • Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christopher D Lao, Principal Investigator, SWOG Cancer Research Network

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