Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
-
Drug: Gleevec (imatinib)
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 |
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| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| 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: | January 19, 2012 |
| 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 May 22, 2013