A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

June 23, 2005 updated by: Sequus Pharmaceuticals

Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma

To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

Study Type

Interventional

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, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • 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
      • Houston, Texas, United States, 77074
        • Twelve Oaks Hosp
      • Houston, Texas, United States, 77054
        • Houston Immunological Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Research Center / Clinical Trial Unit

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

18 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 provided these doses have been stable for at least 1 month.
  • Maintenance therapy for tuberculosis, fungal, and herpes infections.
  • Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
  • Foscarnet or ganciclovir for CMV infection.
  • Colony stimulating factors and erythropoietin.

Patients must have:

  • Moderate to severe AIDS-related Kaposi's sarcoma.
  • Documented anti-HIV antibody.
  • No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).

NOTE:

  • Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Clinically significant cardiac disease.
  • Confusion or disorientation.

Concurrent Medication:

Excluded:

  • Other cytotoxic cancer chemotherapy.

Patients with the following prior conditions are excluded:

  • Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
  • History of idiosyncratic or allergic reaction to anthracyclines.
  • History of major psychiatric illness.

Prior Medication:

Excluded within the past 4 weeks:

  • Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
  • Interferon treatment.

Prior Treatment:

Excluded within the past 3 weeks:

  • Radiation or electron beam therapy.

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
  • Masking: NONE

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

  • Jablonowski H, Szelenyi H, Armbrecht C, Mauss S, Niederau C, Strohmeyer G. Liposomal doxorubicin--a new formulation for the treatment of Kaposi's sarcoma: a study on safety and efficacy in AIDS patients. Int Conf AIDS. 1993 Jun 6-11;9(1):397 (abstract no PO-B12-1573)

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

  • 134C
  • LTI-30-12

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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