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

Phase 1
18 Years
Not Enrolling
Thymic Carcinoma

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.

Outcome Time Frame:

baseline through progression

Safety Issue:


Principal Investigator

Patrick Loehrer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University


United States: Food and Drug Administration

Study ID:

0603-21/ IUCRO-0147



Start Date:

April 2006

Completion Date:

March 2011

Related Keywords:

  • Thymic Carcinoma
  • Thymic malignancy
  • Thymic Carcinoma
  • Carcinoma
  • Thymoma



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265