Clinical Trial: S0331: Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)

Brief Summary: This phase II trial is studying how well imatinib mesylate works in treating patients with metastatic or unresectable Merkel cell cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the feasibility of a Southwest Oncology Group Phase II trial or oral STI-571/imatinib (Gleevec) administered to patients with metastatic or unresectable Merkel cell carcinoma.

II. To evaluate the objective response probability (confirmed and unconfirmed complete and partial responses) of oral STI-571/imatinib (Gleevec) administered to patients with metastatic or unresectable Merkel cell carcinoma.

III. To assess qualitative and quantitative toxicities of oral STI-581/imatinib (Gleevec) administered to patients with metastatic or unresectable Merkel cell carcinoma.

IV. To analyze tumor samples for activating mutations of STI-571/imatinib-sensitive kinases (KIT, PDGFRA, PDGFRB) by denaturing HPLC and direct DNA sequencing.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or symptomatic deterioration.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response probability [ Time Frame: Up to 4 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Toxicity rates [ Time Frame: Up to 4 years ]
    Estimated with 95% confidence interval.
  • Mutation rate for KIT [ Time Frame: Baseline ]
    Estimated with 95% confidence interval.
  • Mutation rate for PDGFRA [ Time Frame: Baseline ]
    Estimated with 95% confidence interval.
  • Mutation rate for PDGFRB [ Time Frame: Baseline ]
    Estimated with 95% confidence intervals.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 10, 2003
Date Started: October 2003
Date Completion:
Last Updated: February 27, 2013
Last Verified: February 2013