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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.

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

MedlinePlus related topics:   AIDS    Kaposi's Sarcoma    Soft Tissue Sarcoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Daunorubicin hydrochloride    Daunorubicin    Vincristine sulfate    Vincristine    Bleomycin    Bleomycin sulfate   

U.S. FDA Resources

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.
  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
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002093
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
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Vincristine
Bleomycin
Doxorubicin
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Infection
Antibiotics, Antineoplastic
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Lentivirus Infections
Neoplasms, Vascular Tissue
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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