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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00314873
First received: April 13, 2006
Last updated: May 30, 2014
Last verified: May 2014
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma

Resource links provided by NLM:


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
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gleevec (imatinib)
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00314873     History of Changes
Other Study ID Numbers: 0603-21/ IUCRO-0147
Study First Received: April 13, 2006
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Thymic malignancy
Thymic Carcinoma

Additional relevant MeSH terms:
Carcinoma
Thymoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014