Trials / Completed
CompletedNCT00068783
S0331: Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer
A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
- Recurrent Neuroendocrine Carcinoma of the Skin
- Stage II Neuroendocrine Carcinoma of the Skin
- Stage III Neuroendocrine Carcinoma of the Skin
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | imatinib mesylate | Given orally |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2003-10-01
- Primary completion
- 2007-06-01
- First posted
- 2003-09-11
- Last updated
- 2013-02-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00068783. Inclusion in this directory is not an endorsement.