Completed

Single-Dose SnET2 and Photodynamic Therapy Light Treatment for Cutaneous AIDS-Related Kaposi's Sarcoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Tin ethyl etiopurpurin

Drug
Who is being recruted

Blood-Borne Infections+25

+ Urogenital Diseases

+ Genital Diseases

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

Treatment Study

Phase 2
Interventional
See protocol details

Summary

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

All patients receive a single dose of SnET2 and are randomized to receive either PDT light treatment or no light treatment (control group). Patients are assessed prior to and at 4, 12 and 24 weeks following treatment, and are followed for 7 months.

NCT00002167
Principal SponsorClinical Solutions
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

78 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 DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueAcquired Immunodeficiency SyndromeSarcoma, KaposiSkin NeoplasmsHIV Infections

Criteria

5 inclusion criteria required to participate
A minimum of 4 and no more than 36 KS lesions
ACTG disease state T(0) L(0) or (1) S(0) or (1)
All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and <= 40 mm in diameter of the longest bidimensional axis
Documentation of at least one biopsy-confirmed KS lesion
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15 exclusion criteria prevent from participating
Active opportunistic infection or condition except thrush or herpes simplex virus infections
Advanced KS tumor stages including the presence of tumor associated edema or ulceration, extensive oral KS, or KS in other non-nodal viscera
Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction
Coagulation dysfunction
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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 6 locations

Univ of Southern California / Los Angeles

Los Angeles, United StatesOpen Univ of Southern California / Los Angeles in Google Maps

Cedars Sinai Med Ctr

Los Angeles, United States

Univ of California / San Francisco / Dermatology

San Francisco, United States

Health One - Rocky Mountain Cancer Ctr

Denver, United States
Completed6 Study Centers