Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045669
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2002-09-06
Brief Title:
Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
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 andor metastatic salivary gland cancer
PURPOSE Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have unresectable andor 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 andor 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 andor 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5663 | OTHER_GRANT | NCI | None |
| PMH-PHL-009 | OTHER | None | None |