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

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”

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.

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.

Intervention(s) in this Clinical Trial

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sequus Pharmaceuticals Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002318

Study ID Number: 134A

ClinicalTrials.gov Identifier: NCT00002318

Health Authority: United States: Food and Drug Administration