Completed
Stealth Liposomal Doxorubicin HCl (DOX-SL) for Moderate to Severe AIDS-Related Kaposi's Sarcoma
What is being tested
Doxorubicin hydrochloride (liposomal)
Drug
Who is being recruted
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+8 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 receive DOX-SL every 3 weeks for up to 20 cycles.
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.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
3 inclusion criteria required to participate
EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL.
AIDS-related Kaposi's sarcoma that requires systemic chemotherapy.
Prior anthracyclines.
5 exclusion criteria prevent from participating
Eligibility for a Liposomal Technology comparative protocol.
Cardiac ejection fraction < 50 percent or clinically significant cardiac disease.
History of idiosyncratic or allergic reaction to anthracyclines.
Other cytotoxic chemotherapy.
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 1 location
CompletedOne Study Center