Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: Cancer and Leukemia Group B
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed small cell lung cancer (SCLC)

• No mixed histology

• Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)

• c-Kit positive by immunohistochemistry (at least 1+)

• At least 1 unidimensionally measurable lesion

• Longest diameter at least 20 mm

• No uncontrolled CNS metastasis

• Treated CNS metastasis allowed

• Performance status - ECOG 0-2

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Direct bilirubin no greater than ULN

• Creatinine no greater than 1.5 times ULN

• No unstable angina pectoris

• No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40%

• No myocardial infarction within the past 3 months

• No uncontrolled infection

• No other malignancy within the past 3 years except skin cancer or localized prostate cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 3 months after study participation

• See Disease Characteristics

• More than 3 weeks since prior chemotherapy

• More than 2 weeks since prior radiotherapy

• No concurrent radiotherapy(including palliative therapy for bone pain)

• Concurrent whole-brain radiotherapy for CNS progression allowed

• More than 3 weeks since prior major surgery

• No prior imatinib mesylate