Completed
SU5416 Dose Escalation in Cutaneous AIDS-Related Kaposi's Sarcoma
What is being tested
SU5416
Drug
Who is being recruted
Blood-Borne Infections+23
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorSUGEN
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.
Principal SponsorSUGEN
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
30 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 by SiteNeoplasms, Vascular TissueRetroviridae InfectionsRNA Virus InfectionsSarcomaSexually Transmitted DiseasesSkin DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueSarcoma, KaposiSkin NeoplasmsHIV Infections
Criteria
5 inclusion criteria required to participate
Agree to use effective methods of birth control during the study
Are HIV-positive
Are at least 18 years old
Have KS with at least 5 skin lesions
Show More Criteria
7 exclusion criteria prevent from participating
Are allergic to Cremophor
Are pregnant
Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers
Have had surgery within 4 weeks of study entry
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
UCLA Care Ctr / Ctr for Hlth Sciences
Los Angeles, United StatesSaint Francis Mem Hosp / HIV Care Unit
San Francisco, United StatesNew York Univ Med Ctr
New York, United StatesCompleted4 Study Centers