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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

Phase 3
18 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

Thank you

Trial Information

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

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- 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

- Life expectancy > 4 months.


- 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:


- 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

- History of major psychiatric illness.

Prior Medication:


- Cytotoxic chemotherapy or interferon therapy within the past 4 weeks.

- More than one prior cycle of bleomycin/vincristine at any time.

Prior Treatment:


- Radiation or electron beam therapy within the past 3 weeks.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Vincristine
  • Sarcoma, Kaposi
  • Liposomes
  • Doxorubicin
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Bleomycin
  • Drug Carriers
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



Mount Sinai Med Ctr New York, New York  10029
Beth Israel Hosp Boston, Massachusetts  02215
Twelve Oaks Hosp Houston, Texas  77074
Virginia Mason Research Center / Clinical Trial Unit Seattle, Washington  98101