We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002093
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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.

Condition Intervention Phase
Sarcoma, Kaposi HIV Infections Drug: Daunorubicin (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002093


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

Publications:
Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64.
Savage GE, Gable C, Motte K, Dixon C, Becker R. A pharmacoeconomic analysis of Kaposi's sarcoma patients based on a clinical trial of ABV vs. DaunoXome. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):32 (abstract no LBB6048)

ClinicalTrials.gov Identifier: NCT00002093     History of Changes
Other Study ID Numbers: 121A
103-09
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: March 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Vincristine
Sarcoma, Kaposi
Liposomes
Doxorubicin
Acquired Immunodeficiency Syndrome
Bleomycin
Daunorubicin
Drug Carriers

Additional relevant MeSH terms:
HIV Infections
Doxorubicin
Liposomal doxorubicin
Sarcoma
Sarcoma, Kaposi
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Daunorubicin
Bleomycin
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators


To Top