Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
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ClinicalTrials.gov Identifier: NCT00090987 |
Recruitment Status :
Completed
First Posted : September 8, 2004
Results First Posted : July 26, 2011
Last Update Posted : June 6, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Drug: imatinib mesylate | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Imatinib mesylate
Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months
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Drug: imatinib mesylate
400 mg orally once a day for up to 6 months.
Other Name: Gleevec |
- Proportion of Patients Who Achieve a Clinical Response [ Time Frame: 20-24 weeks ]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 ]
- Cytokine Profiles Before and After Imatinib Therapy [ Time Frame: 12 months ]
- Pharmacokinetic Profile of Imatinib and Antiretrovirals [ Time Frame: 12 months ]
- Mechanisms of Primary and Secondary Resistance to Imatinib Therapy [ Time Frame: 12 months ]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 ]

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed Kaposi's sarcoma (KS) involving at least 1 of the following areas:
- Skin
- Lymph nodes
- Oral cavity
- Gastrointestinal tract*
- Lungs* NOTE: *Must be asymptomatic or minimally symptomatic AND does not require systemic cytotoxic therapy
- Serological documentation of HIV infection, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), Western Blot test, or other federally approved licensed HIV test
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At least 5 measurable, non-irradiated, cutaneous indicator lesions
- Patients must have 3 lesions at least 5 x 5 mm that are accessible for 4 mm punch biopsy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- At least 3 months
Hematopoietic
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal
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Bilirubin normal
- Patients with elevated bilirubin secondary to indinavir or atazanavir allowed provided total bilirubin is < 3.5 mg/dL AND direct bilirubin is normal
-
No acute or known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
- Hepatitis C infection with minimal or no fibrosis on liver biopsy allowed
Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance > 60 mL/min
Cardiovascular
- No New York Heart Association class III or IV cardiac disease
- No congestive heart failure
- No myocardial infarction within the past 6 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- No concurrent active opportunistic infection
- No other severe and/or life-threatening medical disease
- No other malignancy within the past 5 years except clinically insignificant malignancy not requiring active intervention, basal cell skin cancer, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior biologic therapy for KS
- More than 2 weeks since prior granulocyte colony-stimulating factor
- No concurrent biologic agents for KS
Chemotherapy
- More than 4 weeks since prior chemotherapy for KS (6 weeks for nitrosoureas or mitomycin)
- No concurrent chemotherapy for KS, including systemic cytotoxic chemotherapy
Endocrine therapy
- No concurrent systemic corticosteroid therapy except replacement doses
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy for KS
- No concurrent radiotherapy for KS
Surgery
- More than 2 weeks since prior major surgery
Other
- No prior imatinib mesylate
- More than 60 days since prior local therapy to any KS indicator lesion unless the lesion has progressed since treatment
- More than 4 weeks since prior investigational therapy for KS
- More than 4 weeks since other prior therapy for KS
- More than 14 days since prior acute treatment for an infection or other serious medical illness
- No concurrent warfarin
- No concurrent grapefruit juice
- No other concurrent therapy for KS
- No other concurrent investigational drugs
- Concurrent antiretroviral therapy required except for patients who have exhausted all available treatment options

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090987
United States, California | |
Moores UCSD Cancer Center | |
La Jolla, California, United States, 92093-0658 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
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 |
Documents provided by AIDS Malignancy Consortium:
Responsible Party: | AIDS Malignancy Consortium |
ClinicalTrials.gov Identifier: | NCT00090987 |
Other Study ID Numbers: |
AMC-042 U01CA070019 ( U.S. NIH Grant/Contract ) CDR0000380955 ( Other Identifier: NCI ) |
First Posted: | September 8, 2004 Key Record Dates |
Results First Posted: | July 26, 2011 |
Last Update Posted: | June 6, 2018 |
Last Verified: | May 2018 |
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Sarcoma, Kaposi Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections |
Virus Diseases Neoplasms, Vascular Tissue Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |