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

Study Overview
=================
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 evaluate other combination of drugs with imatinib in thymic tumors.

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 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.

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

Conditions
-----------------
Thymic Carcinoma

Intervention / Treatment
-----------------
* Drug: Gleevec (imatinib)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gleevec (imatinib)|Imatinib 600mg po qd X 21 days.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma. |  | baseline through progression | 
| To determine the duration of remission of patients with thymic carcinoma treated with imatinib. |  | baseline through progression | 
| To determine the toxicity of imatinib in this patient population. |  | baseline through end of study | 
| To determine the incidence of kit mutations in thymic malignancies. |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thymic malignancy, Thymic Carcinoma