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

Indiana University School of Medicine

Status and phase

Completed

Phase 1

Conditions

Thymic Carcinoma

Treatments

Drug: Gleevec (imatinib)

Study type

Interventional

Funder types

Other

Identifiers

NCT00314873

0603-21/ IUCRO-0147

Details and patient eligibility

About

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.

Full 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 necessitates the need for systemic therapy. Due to the paucity of thymic carcinoma cases, the ideal regimen for locally advanced or metastatic thymic carcinomas is not defined.To this point, there has not been a study using imatinib in thymic tumors expressing the KIT tyrosine kinase protein or PDGF tyrosine kinase protein. 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.