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A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

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ClinicalTrials.gov Identifier: NCT00002318
Recruitment Status : Unknown
Verified January 1996 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

Condition or disease Intervention/treatment Phase
Sarcoma, Kaposi HIV Infections Drug: Doxorubicin hydrochloride (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Phase 3

Detailed Description:
Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 225 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
  • Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
  • Foscarnet for new episodes of cytomegalovirus infection.
  • Colony-stimulating factors and erythropoietin.

Patients must have:

  • Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
  • At least 25 mucocutaneous lesions.
  • Ten or more new lesions in the prior month.
  • Documented visceral disease with at least two accessible cutaneous lesions.
  • Two accessible cutaneous lesions with edema.
  • Documented anti-HIV antibody.
  • No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
  • Life expectancy > 4 months.

NOTE:

  • Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Clinically significant cardiac, hepatic, or renal disease.
  • Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
  • Inability to comply with the study.

Concurrent Medication:

Excluded:

  • Other cytotoxic chemotherapy.
  • Ganciclovir.

Patients with the following prior conditions are excluded:

  • Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
  • History of idiosyncratic or allergic reaction to bleomycin or vincristine.

Prior Medication:

Excluded:

  • Prior anthracycline therapy.
  • Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.

Prior Treatment:

Excluded:

  • Radiation or electron beam therapy within the past 3 weeks.
Contacts and Locations
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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): NCT00002318


Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
Hematology - Oncology Med Group of San Fernando Valley
Encino, California, United States, 91436
Dr Becky Miller
Los Angeles, California, United States, 90048
Apogee Med Group
San Diego, California, United States, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
UCSF
San Francisco, California, United States, 94117
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
UCSF
San Francisco, California, United States, 941430324
Pacific Oaks Med Group
Sherman Oaks, California, United States, 91403
United States, District of Columbia
Dr Mahmoud Mustafa
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
American Med Research Institute
Atlanta, Georgia, United States, 30329
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, United States, 30345
United States, Illinois
Northwestern Med Faculty Foundation
Chicago, Illinois, United States, 60611
Rush Presbyterian Med College
Chicago, Illinois, United States, 60612
Illinois Masonic Med Ctr / The Cancer Ctr
Chicago, Illinois, United States, 60657
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, Missouri
Washington Univ
St Louis, Missouri, United States, 63108
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
New York Univ Med Ctr
New York, New York, United States, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10023
United States, Pennsylvania
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Comprehensive Care Ctr
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sequus Pharmaceuticals
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00002318     History of Changes
Other Study ID Numbers: 134A
LTI-30-10
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1996

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

Additional relevant MeSH terms:
HIV Infections
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
Doxorubicin
Liposomal doxorubicin
Bleomycin
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents