Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00045669
Study type	Interventional
Source	University Health Network, Toronto
Contact
Status	Completed
Phase	Phase 2
Start date	July 2002
Completion date	January 2005

View Details

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