A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Overview
- Phase
- Phase 2
- Intervention
- imatinib mesylate
- Conditions
- Recurrent Neuroendocrine Carcinoma of the Skin
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Response probability
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have a biopsy-proven diagnosis of Merkel Cell Carcinoma (Cutaneous Neuroendocrine Carcinoma) that is distantly metastatic or unresectable
- •Tumors must beet BOTH of the following criteria:
- •The primary must be of skin origin; (patients with unknown primary are not eligible)
- •All patients must have immunohistochemical staining with c-kit (CD117) expression by tumor documented by DAKO, Benchmark, or similar staining kit
- •The institution must plan to submit materials for pathology review
- •NOTE: Submission of additional specimens is strongly encouraged
- •Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT or MRI scan or plain X-ray) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration
- •Patients with symptomatic, unstable or untreated brain metastases are not eligible; previous treatment must have been completed at least 28 days prior to registration
- •Patients must have a Zubrod performance status of 0-2
- •Patients must not have received radiotherapy, chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to registration; all toxicities from prior treatment must have been resolved (in the opinion of the treating investigator); patients whose only disease is within a previous radiation therapy port must demonstrate clearly progressive disease prior to registration; patients must have resolution of all toxicities from any prior therapy to =\< grade 1 (CTCAE version 3.0); patients must not have had a major surgery (e.g., large chest and abdominal incisions, major soft tissue resections) within 14 days prior to registration
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment
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.
Intervention: imatinib mesylate
Treatment
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Response probability
Time Frame: Up to 4 years
Secondary Outcomes
- Mutation rate for PDGFRA(Baseline)
- Toxicity rates(Up to 4 years)
- Mutation rate for KIT(Baseline)
- Mutation rate for PDGFRB(Baseline)