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Completed

NCT Number: NCT00314873

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gleevec (imatinib)

Drug

Imatinib 600mg po qd X 21 days.

Primary outcomes

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

    Time frame: baseline through progression

  2. To determine the duration of remission of patients with thymic carcinoma treated with imatinib.

    Time frame: baseline through progression

  3. To determine the toxicity of imatinib in this patient population.

    Time frame: baseline through end of study

  4. To determine the incidence of kit mutations in thymic malignancies.

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Apr 17, 2006
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.