Clinical Trial: Dinaciclib in Treating Patients With Stage IV Melanoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 enzymes needed for cell growth.

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: 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.


Original Primary Outcome:

  • 1-year overall survival
  • 6-month progression-free survival


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Complete and partial response rate
  • Safety as per NCI CTCAE v.3.0


Information By: National Cancer Institute (NCI)

Dates:
Date Received: July 10, 2009
Date Started: July 2009
Date Completion:
Last Updated: May 8, 2017
Last Verified: December 2016