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

NCT00090987 | Completed Phase 2 Results

• 3 other identifiers: AMC-042U01CA070019CDR0000380955
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcoma; recurrent Kaposi sarcoma

Outcome Measures

Primary Outcomes (1)

• 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

  20-24 weeks

Secondary Outcomes (5)

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

  12 months

• Cytokine Profiles Before and After Imatinib Therapy

  12 months

• Pharmacokinetic Profile of Imatinib and Antiretrovirals

  12 months

• Mechanisms of Primary and Secondary Resistance to Imatinib Therapy

  12 months

• Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus

  12 months

Study Arms (1)

Imatinib mesylate

EXPERIMENTAL

Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months

Drug: imatinib mesylate

Interventions

imatinib mesylate DRUG

400 mg orally once a day for up to 6 months.

Also known as: Gleevec

Imatinib mesylate

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (15)

Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Desert Regional Medical Center Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Joan Karnell Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (3)

• 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.

  PMID: 16687713 BACKGROUND

• 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.

  PMID: 16862153 BACKGROUND

• 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.

  PMID: 24378417 BACKGROUND

MeSH Terms

Conditions

Sarcoma; AIDS-related Kaposi sarcoma; Sarcoma, Kaposi

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Jeannette Y. Lee, Director of Statistical Center
• Organization: AMC

jylee@uams.edu

(501) 526-6712

Study Officials

• Ariela Noy, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

• Henry Koon, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: June 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 6, 2018
• Results First Posted: July 26, 2011

Record last verified: 2018-05

Locations

US (15)