Completed

DOX-SL vs Bleomycin and Vincristine for AIDS-Related Kaposi's Sarcoma Treatment

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What is being tested

Doxorubicin hydrochloride (liposomal)

+ Bleomycin sulfate

+ Vincristine sulfate

Drug
Who is being recruted

Blood-Borne Infections+21

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorSequus Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002105
Principal SponsorSequus Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissueRetroviridae InfectionsRNA Virus InfectionsSarcomaSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsNeoplasms, Connective and Soft TissueAcquired Immunodeficiency SyndromeSarcoma, KaposiHIV Infections

Criteria

9 inclusion criteria required to participate
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
Erythropoietin
Foscarnet for cytomegalovirus infection
Show More Criteria
11 exclusion criteria prevent from participating
Clinically significant cardiac disease
Colony-stimulating factors
Confusion, disorientation, CNS symptoms, or peripheral neuropathy
Cytotoxic chemotherapy or interferon therapy within the past 4 weeks
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Beth Israel Hosp

Boston, United StatesOpen Beth Israel Hosp in Google Maps

Mount Sinai Med Ctr

New York, United States

Twelve Oaks Hosp

Houston, United States

Virginia Mason Research Center / Clinical Trial Unit

Seattle, United States
Completed4 Study Centers