Suspended
DOX-SL vs ABV for Severe AIDS-Related Kaposi's Sarcoma Treatment
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
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
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 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.
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
225 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
12 inclusion criteria required to participate
Allowed: Colony-stimulating factors and erythropoietin
Allowed: Foscarnet for new episodes of cytomegalovirus infection
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
Allowed: Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy
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10 exclusion criteria prevent from participating
Clinically significant cardiac, hepatic, or renal disease
Cytotoxic chemotherapy or interferon treatment within the past 4 weeks
Ganciclovir
History of idiosyncratic or allergic reaction to bleomycin or vincristine
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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 28 locations
Pacific Oaks Med Group
Beverly Hills, United StatesHematology - Oncology Med Group of San Fernando Valley
Encino, United StatesDr Becky Miller
Los Angeles, United StatesSuspended28 Study Centers