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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Nexstar Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002093
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized
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:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
Desert Hosp Comprehensive Cancer Ctr
Palm Springs, California, United States, 92262
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)

Study ID Numbers: 121A, 103-09
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002093     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Daunorubicin
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Vincristine
Antimitotic Agents
Bleomycin
Doxorubicin
Immunologic Deficiency Syndromes
Kaposi Sarcoma
Herpesviridae Infections
Virus Diseases
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
HIV Infections
Tubulin Modulators
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Antineoplastic Agents, Phytogenic
Retroviridae Infections

Additional relevant MeSH terms:
Daunorubicin
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Infection
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Therapeutic Uses
Neoplasms, Vascular Tissue
Retroviridae Infections
RNA Virus Infections
Neoplasms by Histologic Type
Immune System Diseases
Mitosis Modulators
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Vincristine
Antimitotic Agents
Bleomycin
Pharmacologic Actions
Immunologic Deficiency Syndromes
Doxorubicin
Herpesviridae Infections
Virus Diseases
Neoplasms
HIV Infections
Tubulin Modulators
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on September 02, 2009