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Status:

COMPLETED

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

Lead Sponsor:

AIDS Malignancy Consortium

Collaborating Sponsors:

National Cancer Institute (NCI)

The Emmes Company, LLC

Conditions:

Sarcoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

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 treati...

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 fact...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2009

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00090987

    Start Date

    June 1 2005

    End Date

    December 1 2009

    Last Update

    June 6 2018

    Active Locations (15)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (15 locations)

    1

    Moores UCSD Cancer Center

    La Jolla, California, United States, 92093-0658

    2

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    3

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    4

    Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, United States, 92262