Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Histological or cytological proof of advanced C-KIT positive or PDGFR positive thymic carcinoma. For protocol purposes, advanced disease is defined as disease

• Patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.

• No prior imatinib therapy.

• Age > 18 years at the time of consent

• ECOG performance status of 0 or 1

• ANC ≥ 1500/mm3,Platelet count ≥ 100,000/mm,Total bilirubin < 1.5ULN,3.10 Serum creatinine ≤ 1.7 mg/dl,ALT and AST ≤ 3 x ULN

Exclusion Criteria:

• Clinically significant infections as judged by the treating investigator

• Clinically significant concurrent illnesses

• Females of childbearing potential not using birth control or breastfeeding

• Prior radiation therapy > 25% of the bone marrow

• Symptomatic brain metastasis

• History of Grade III/IV cardiac problems

• History of major surgery within 14 days prior to being registered

• Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.