Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
NCT ID: NCT00090987
Last Updated: 2018-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2005-06-30
2009-12-31
Brief Summary
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PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposi's sarcoma.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Imatinib mesylate
Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months
imatinib mesylate
400 mg orally once a day for up to 6 months.
Interventions
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imatinib mesylate
400 mg orally once a day for up to 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Ariela Noy, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Henry Koon, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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Moores UCSD Cancer Center
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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References
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Berman E, Nicolaides M, Maki RG, Fleisher M, Chanel S, Scheu K, Wilson BA, Heller G, Sauter NP. Altered bone and mineral metabolism in patients receiving imatinib mesylate. N Engl J Med. 2006 May 11;354(19):2006-13. doi: 10.1056/NEJMoa051140.
Kerkela R, Grazette L, Yacobi R, Iliescu C, Patten R, Beahm C, Walters B, Shevtsov S, Pesant S, Clubb FJ, Rosenzweig A, Salomon RN, Van Etten RA, Alroy J, Durand JB, Force T. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat Med. 2006 Aug;12(8):908-16. doi: 10.1038/nm1446. Epub 2006 Jul 23.
Koon HB, Krown SE, Lee JY, Honda K, Rapisuwon S, Wang Z, Aboulafia D, Reid EG, Rudek MA, Dezube BJ, Noy A. Phase II trial of imatinib in AIDS-associated Kaposi's sarcoma: AIDS Malignancy Consortium Protocol 042. J Clin Oncol. 2014 Feb 10;32(5):402-8. doi: 10.1200/JCO.2012.48.6365. Epub 2013 Dec 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CDR0000380955
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-042
Identifier Type: -
Identifier Source: org_study_id
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