A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

June 23, 2005 updated by: Nexstar Pharmaceuticals
To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Univ of Arizona / Arizona Cancer Ctr
    • California
      • Los Angeles, California, United States, 90033
        • Kenneth Norris Jr Cancer Hosp
      • Palm Springs, California, United States, 92262
        • Desert Hosp Comprehensive Cancer Ctr
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp
    • Colorado
      • Denver, Colorado, United States, 802044507
        • Denver Gen Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami Dept of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • New England Deaconess Hosp
    • New York
      • New York, New York, United States, 10016
        • New York Univ Med Ctr
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Med Ctr
    • Texas
      • Houston, Texas, United States, 77004
        • Dr Edward Stool

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

Patients must have:

  • HIV infection.
  • Advanced Kaposi's sarcoma.

Prior Medication:

Allowed:

  • Prior intralesional vinblastine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Acute intercurrent infection other than genital herpes.
  • Uncompensated cardiovascular, hepatic, renal, or pulmonary disease unrelated to Kaposi's sarcoma.
  • Symptomatic peripheral neuropathy.
  • Any condition that compromises ability to give informed consent or complete the study.

Concurrent Medication:

Excluded:

  • Concurrent ganciclovir.

Patients with the following prior conditions are excluded:

  • Symptomatic AIDS-defining opportunistic infection within 2 weeks of entry.
  • History of malignancy other than Kaposi's sarcoma, basal cell carcinoma, or carcinoma in situ of the cervix.

Prior Medication:

Excluded:

  • Prior systemic chemotherapy.
  • Intralesional therapies within 7 days prior to study entry.
  • Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry.
  • Interferon preparations (alpha or beta) within 28 days prior to study entry.

Prior Treatment:

Excluded within 7 days prior to study entry:

  • Radiation.
  • Local therapies (e.g., cryotherapy).

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
  • Allocation: Randomized

Collaborators and Investigators

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

Sponsor

Nexstar 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

March 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121A
  • 103-09

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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