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

Thymic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314873
• Other study ID #: 0603-21/ IUCRO-0147
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2006
• Last updated: May 30, 2014
• Start date: April 2006
• Est. completion date: March 2011

Study information

• Verified date: May 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Thymic Carcinoma
• Thymoma

Intervention

Drug:
• Gleevec (imatinib)
Imatinib 600mg po qd X 21 days.

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.		baseline through progression	No
Primary	To determine the duration of remission of patients with thymic carcinoma treated with imatinib.		baseline through progression	No
Primary	To determine the toxicity of imatinib in this patient population.		baseline through end of study	Yes
Primary	To determine the incidence of kit mutations in thymic malignancies.		baseline	No

External Links

•   Find a Clinical Trial: Click Thymoma and Thymic Carcinoma