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

NCT00314873 | Completed Phase 1

• 1 other identifier: 0603-21/ IUCRO-0147
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Thymic Carcinoma

Keywords

Thymic malignancy; Thymic Carcinoma

Outcome Measures

Primary Outcomes (4)

• To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.

  baseline through progression

• To determine the duration of remission of patients with thymic carcinoma treated with imatinib.

  baseline through progression

• To determine the toxicity of imatinib in this patient population.

  baseline through end of study

• To determine the incidence of kit mutations in thymic malignancies.

  baseline

Interventions

Gleevec (imatinib) DRUG

Imatinib 600mg po qd X 21 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Thymoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Patrick Loehrer

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

US (1)