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

S

Sequus Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Sarcoma, Kaposi
HIV Infections

Treatments

Drug: Vincristine sulfate
Drug: Doxorubicin hydrochloride (liposomal)
Drug: Bleomycin sulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002105
134B
LTI-30-11

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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