Clinical trial NCT00002318: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Vincristine
Sarcoma, Kaposi
Liposomes
Doxorubicin
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Bleomycin
Drug Carriers
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Beverly Hills
country: United States
facility: Pacific Oaks Med Group
state: California
city: Encino
country: United States
facility: Hematology - Oncology Med Group of San Fernando Valley
state: California
city: Los Angeles
country: United States
facility: Dr Becky Miller
state: California
city: San Diego
country: United States
facility: Apogee Med Group
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Sherman Oaks
country: United States
facility: Pacific Oaks Med Group
state: California
city: Washington
country: United States
facility: Dr Mahmoud Mustafa
state: District of Columbia
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: H Lee Moffit Cancer Ctr and Research Institute
state: Florida
city: Atlanta
country: United States
facility: American Med Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Infectious Disease Rsch Consortium of GA / SE Clin Resources
state: Georgia
city: Chicago
country: United States
facility: Northwestern Med Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian Med College
state: Illinois
city: Chicago
country: United States
facility: Illinois Masonic Med Ctr / The Cancer Ctr
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: St Louis
country: United States
facility: Washington Univ
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Saint Vincent's Hosp and Med Ctr
state: New York
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: Philadelphia
country: United States
facility: Graduate Hosp / Tuttleman Cancer Ctr
state: Pennsylvania
city: Dallas
country: United States
facility: Comprehensive Care Ctr
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. doi: 10.1200/JCO.1996.14.8.2353.