Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090987
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2004-09-07
Brief Title:
Imatinib Mesylate in Treating Patients With HIV-Related Kaposis Sarcoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
A Phase II Trial Of Imatinib Mesylate Gleevec In Patients With HIV Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2018-05
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 their growth
PURPOSE This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposis sarcoma
PURPOSE This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposis sarcoma
Detailed Description:
OBJECTIVES
Primary
Determine clinical response in patients with HIV-related Kaposis sarcoma treated with imatinib mesylate
Secondary
Determine the inhibition of platelet-derived growth factor receptors as determined by immunohistochemistry in patients treated with this drug
Determine cytokine profiles before and after treatment with this drug in these patients
Determine the pharmacokinetic profile of this drug and antiretrovirals in these patients
Determine mechanisms of primary and secondary resistance to this drug in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral imatinib mesylate once daily Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 1 year
Primary
Determine clinical response in patients with HIV-related Kaposis sarcoma treated with imatinib mesylate
Secondary
Determine the inhibition of platelet-derived growth factor receptors as determined by immunohistochemistry in patients treated with this drug
Determine cytokine profiles before and after treatment with this drug in these patients
Determine the pharmacokinetic profile of this drug and antiretrovirals in these patients
Determine mechanisms of primary and secondary resistance to this drug in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral imatinib mesylate once daily Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000380955 | OTHER | NCI | httpsreporternihgovquickSearchU01CA070019 |
| U01CA070019 | NIH | None | None |