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Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma

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ClinicalTrials.gov Identifier: NCT00002105
Recruitment Status : Completed
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 moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.

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

Detailed Description:
Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 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 who respond to therapy will be followed every 2 months for up to 1 year. Patients must agree to have one or more representative KS lesions biopsied.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of 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.
  • Maintenance therapy for tuberculosis, fungal, and herpes infections.
  • Therapy for new episodes of tuberculosis, fungal, and herpes infection except with potentially myelotoxic chemotherapy.
  • Foscarnet for cytomegalovirus infection.
  • Erythropoietin.

Patients must have:

  • Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
  • At least 15 mucocutaneous lesions.
  • Six or more new lesions in the prior month.
  • Documented visceral disease with at least five accessible cutaneous lesions.
  • Documented anti-HIV antibody.
  • No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING treatment with myelotoxic drugs).
  • Life expectancy > 4 months.

NOTE:

  • Patients who fail the BV combination or who relapse 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 disease.
  • Confusion, disorientation, CNS symptoms, or peripheral neuropathy.

Concurrent Medication:

Excluded:

  • Other cytotoxic chemotherapy.
  • Colony-stimulating factors.
  • 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 anthracyclines, bleomycin, or vincristine.
  • History of major psychiatric illness.

Prior Medication:

Excluded:

  • Cytotoxic chemotherapy or interferon therapy within the past 4 weeks.
  • More than one prior cycle of bleomycin/vincristine at any time.

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): NCT00002105


Locations
United States, Massachusetts
Beth Israel Hosp
Boston, Massachusetts, United States, 02215
United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
United States, Texas
Twelve Oaks Hosp
Houston, Texas, United States, 77074
United States, Washington
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Sequus Pharmaceuticals
More Information
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Publications:
Stewart S, Jablonowski H, Goebel FD, L'Age M, Spittle M, Luthy R. Randomized comparative trial of DOXIL vs. Bleomycin and Vincristine in the treatment of AIDS-Related KS. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):27 (abstract no LBB6026)

ClinicalTrials.gov Identifier: NCT00002105     History of Changes
Other Study ID Numbers: 134B
LTI-30-11
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