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

Information source: AIDS Malignancy Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoma

Intervention: imatinib mesylate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AIDS Malignancy Consortium

Official(s) and/or principal investigator(s):
Ariela Noy, MD, Study Chair, Affiliation: Memorial Sloan Kettering Cancer Center
Henry Koon, MD, Study Chair, Affiliation: Beth Israel Deaconess Medical Center

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of Patients Who Achieve a Clinical Response

Secondary outcome:

Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry

Cytokine Profiles Before and After Imatinib Therapy

Pharmacokinetic Profile of Imatinib and Antiretrovirals

Mechanisms of Primary and Secondary Resistance to Imatinib Therapy

Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

- 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

Locations and Contacts

Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 90095-1781, United States

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90089-9181, United States

Desert Regional Medical Center Comprehensive Cancer Center, Palm Springs, California 92262, United States

UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York 10461, United States

Memorial Sloan - Kettering Cancer Center, New York, New York 10021, United States

Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States

Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania 19106, United States

Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center, Seattle, Washington 98101, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Related publications:

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.

Kerkelä 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. Epub 2006 Jul 23.

Starting date: June 2005
Last updated: August 27, 2014

Page last updated: August 23, 2015

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