A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

June 23, 2005 updated by: Sequus Pharmaceuticals

Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.

Study Type

Interventional

Enrollment

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Med Group
      • Encino, California, United States, 91436
        • Hematology - Oncology Med Group of San Fernando Valley
      • Los Angeles, California, United States, 90048
        • Dr Becky Miller
      • San Diego, California, United States, 92103
        • Apogee Med Group
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Administration Med Ctr
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Med Ctr
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
      • San Francisco, California, United States, 94117
        • UCSF
      • San Francisco, California, United States, 941430324
        • UCSF
      • Sherman Oaks, California, United States, 91403
        • Pacific Oaks Med Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Dr Mahmoud Mustafa
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Tampa, Florida, United States, 33612
        • H Lee Moffit Cancer Ctr and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • American Med Research Institute
      • Atlanta, Georgia, United States, 30345
        • Infectious Disease Rsch Consortium of GA / SE Clin Resources
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Med Faculty Foundation
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian Med College
      • Chicago, Illinois, United States, 60657
        • Illinois Masonic Med Ctr / The Cancer Ctr
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington Univ
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10016
        • New York Univ Med Ctr
      • New York, New York, United States, 10011
        • Saint Vincent's Hosp and Med Ctr
      • New York, New York, United States, 10023
        • Saint Luke's - Roosevelt Hosp Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Graduate Hosp / Tuttleman Cancer Ctr
    • Texas
      • Dallas, Texas, United States, 75235
        • Comprehensive Care Ctr
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
  • Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
  • Foscarnet for new episodes of cytomegalovirus infection.
  • Colony-stimulating factors and erythropoietin.

Patients must have:

  • Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
  • At least 25 mucocutaneous lesions.
  • Ten or more new lesions in the prior month.
  • Documented visceral disease with at least two accessible cutaneous lesions.
  • Two accessible cutaneous lesions with edema.
  • Documented anti-HIV antibody.
  • No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
  • Life expectancy > 4 months.

NOTE:

  • Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Clinically significant cardiac, hepatic, or renal disease.
  • Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
  • Inability to comply with the study.

Concurrent Medication:

Excluded:

  • Other cytotoxic chemotherapy.
  • Ganciclovir.

Patients with the following prior conditions are excluded:

  • Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
  • History of idiosyncratic or allergic reaction to bleomycin or vincristine.

Prior Medication:

Excluded:

  • Prior anthracycline therapy.
  • Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.

Prior Treatment:

Excluded:

  • Radiation or electron beam therapy within the past 3 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequus Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 134A
  • LTI-30-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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