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

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ClinicalTrials.gov Identifier: NCT00314873
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thymic Carcinoma Drug: Gleevec (imatinib) Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
Study Start Date : April 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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Arms and Interventions
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Intervention Details:
  • Drug: Gleevec (imatinib)
    Imatinib 600mg po qd X 21 days.

Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314873


Locations
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United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: Patrick Loehrer Indiana University
More Information
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Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00314873    
Other Study ID Numbers: 0603-21/ IUCRO-0147
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Keywords provided by Indiana University ( Indiana University School of Medicine ):
Thymic malignancy
Thymic Carcinoma
Additional relevant MeSH terms:
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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 Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action