NCT00090987

Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma

A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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 Kaposi's sarcoma.

Detailed description

OBJECTIVES: Primary * Determine clinical response in patients with HIV-related Kaposi's 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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	imatinib mesylate	400 mg orally once a day for up to 6 months.

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2004-09-08
• Last updated: 2018-06-06
• Results posted: 2011-07-26

Locations

15 sites across 1 country: United States