Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma|
- Proportion of Patients Who Achieve a Clinical Response [ Time Frame: 20-24 weeks ] [ Designated as safety issue: No ]Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for >4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions
- Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Cytokine Profiles Before and After Imatinib Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Pharmacokinetic Profile of Imatinib and Antiretrovirals [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mechanisms of Primary and Secondary Resistance to Imatinib Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression
- Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Imatinib mesylate
Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months
Drug: imatinib mesylate
400 mg orally once a day for up to 6 months.
Other Name: Gleevec
- Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with imatinib mesylate.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090987
|United States, California|
|Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|Desert Regional Medical Center Comprehensive Cancer Center|
|Palm Springs, California, United States, 92262|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Memorial Sloan - Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|Joan Karnell Cancer Center at Pennsylvania Hospital|
|Philadelphia, Pennsylvania, United States, 19106|
|United States, Washington|
|Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Study Chair:||Ariela Noy, MD||Memorial Sloan Kettering Cancer Center.|
|Study Chair:||Henry Koon, MD||Beth Israel Deaconess Medical Center|