Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: imatinib mesylate

• Registration Number: NCT00045669
• Lead Sponsor: University Health Network, Toronto

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have unresectable and/or metastatic salivary gland cancer.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of imatinib mesylate, in terms of objective response rates (partial and complete responses) and duration of overall response, in patients with unresectable and/or metastatic adenoid cystic, lymphoepithelioma-like, or myoepithelial salivary gland cancer.

* Determine the safety and tolerability of this drug in these patients.

* Correlate the activity of c-kit and downstream kinases in pre- and post-treatment tumoral biopsies with clinical course in patients treated with this drug.

* Determine the effect of treatment with this drug on tumor samples from these patients in terms of proliferation, apoptosis, and angiogenesis.

* Correlate the steady state levels of this drug achieved with clinical and laboratory correlative endpoints in these patients.

* Determine whether early changes in metabolic activity correlate with molecular changes and predict outcome to therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for up to 6 months.

Patients are followed within 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2002-09-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-01
• Study Completion: 2005-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib Mesylate	imatinib mesylate	Adult patients with unresectable or metastatic adenoid cystic carcinoma measurable by Response Evaluation Criteria in Solid Tumors Group criteria and expressing c-kit by immunohistochemistry were treated with imatinib 400 mg orally bid. Response was assessed every 8 weeks

Trial Locations

Locations (15)

Oncology/Hematology Associates of Central Illinois, P.C.; 🇺🇸 Peoria, Illinois, United States

LaGrange Memorial Hospital; 🇺🇸 LaGrange, Illinois, United States

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States

Central Illinois Hematology Oncology Center; 🇺🇸 Springfield, Illinois, United States

Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Louis A. Weiss Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Evanston Northwestern Health Care - Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Incorporated; 🇺🇸 Fort Wayne, Indiana, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute; 🇺🇸 Decatur, Illinois, United States

Ingalls Memorial Hospital; 🇺🇸 Harvey, Illinois, United States

Cancer Care Ontario-Hamilton Regional Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

CCOP - Northern Indiana CR Consortium; 🇺🇸 South Bend, Indiana, United States

Lakeland Medical Center - St. Joseph; 🇺🇸 Saint Joseph, Michigan, United States