Status:
COMPLETED
Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Thymic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 eval...
Detailed Description
Thymic carcinomas are particularly more concerning due to their aggressive metastatic nature and shorter overall survival, in comparison to their lesser-malignant thymoma counterparts. This necessitat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00314873
Start Date
April 1 2006
End Date
March 1 2011
Last Update
June 3 2014
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202