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

NCT ID: NCT00314873

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Thymic Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Gleevec (imatinib)

Imatinib 600mg po qd X 21 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Loehrer

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0603-21/ IUCRO-0147

Identifier Type: -

Identifier Source: org_study_id