A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma
- Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with
- 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
- Determine the pharmacokinetic profile of this drug and antiretrovirals in these
- Determine mechanisms of primary and secondary resistance to this drug in these
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Patients Who Achieve a Clinical Response
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
Ariela Noy, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Joan Karnell Cancer Center at Pennsylvania Hospital||Philadelphia, Pennsylvania 19107|
|Moores UCSD Cancer Center||La Jolla, California 92093-0658|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Desert Regional Medical Center Comprehensive Cancer Center||Palm Springs, California 92262|
|Memorial Sloan - Kettering Cancer Center||New York, New York 10021|
|Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center||Seattle, Washington 98111|