Back to resultsPilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
Primary Purpose
Thymic Carcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gleevec (imatinib)
Sponsored by
About this trial
This is an interventional treatment trial for Thymic Carcinoma focused on measuring Thymic malignancy, Thymic Carcinoma
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.
Sites / Locations
- Indiana University Cancer Center
Outcomes
Primary Outcome Measures
To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.
To determine the duration of remission of patients with thymic carcinoma treated with imatinib.
To determine the toxicity of imatinib in this patient population.
To determine the incidence of kit mutations in thymic malignancies.
Secondary Outcome Measures
Full Information
NCT ID
NCT00314873
First Posted
April 13, 2006
Last Updated
May 30, 2014
Sponsor
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00314873
Brief Title
Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
Official Title
Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymic Carcinoma
Keywords
Thymic malignancy, Thymic Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gleevec (imatinib)
Intervention Description
Imatinib 600mg po qd X 21 days.
Primary Outcome Measure Information:
Title
To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.
Time Frame
baseline through progression
Title
To determine the duration of remission of patients with thymic carcinoma treated with imatinib.
Time Frame
baseline through progression
Title
To determine the toxicity of imatinib in this patient population.
Time Frame
baseline through end of study
Title
To determine the incidence of kit mutations in thymic malignancies.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Loehrer
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
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