Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma - Full Text View

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00314873

Purpose

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.

Condition	Intervention	Phase
Thymic Carcinoma	Drug: Gleevec (imatinib)	Phase I

MedlinePlus related topics: Cancer Thymus Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma

Further study details as provided by Indiana University:

Primary Outcome Measures:

To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma. [ Time Frame: baseline through progression ] [ Designated as safety issue: No ]
To determine the duration of remission of patients with thymic carcinoma treated with imatinib. [ Time Frame: baseline through progression ] [ Designated as safety issue: No ]
To determine the toxicity of imatinib in this patient population. [ Time Frame: baseline through end of study ] [ Designated as safety issue: Yes ]
To determine the incidence of kit mutations in thymic malignancies. [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Imatinib 600mg po qd X 21 days.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314873

Locations

United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Patrick Loehrer

Indiana University

More Information

Find a Clinical Trial: Click Thymoma and Thymic Carcinoma This link exits the ClinicalTrials.gov site

Responsible Party:	Indiana University Cancer Center ( Patrick Loehrer, MD/ Principal Investigator )
Study ID Numbers:	0603-21
Study First Received:	April 13, 2006
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00314873
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indiana University:

Thymic malignancy
Thymic Carcinoma

Study placed in the following topic categories:

Imatinib
Thoracic Neoplasms
Thymoma

Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on January 16, 2009