Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-03 @ 7:28 AM
Study NCT ID:
NCT00045669
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: