Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
1 other identifier
interventional
78
1 country
6
Brief Summary
To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Documentation of at least one biopsy-confirmed KS lesion.
- A minimum of 4 and no more than 36 KS lesions.
- All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and \<= 40 mm in diameter of the longest bidimensional axis.
- ACTG disease state T(0) L(0) or (1) S(0) or (1).
- Life expectancy greater than 6 months.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- 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.
- Hematopoietic dysfunction.
- Coagulation dysfunction.
- Hepatic dysfunction.
- Renal dysfunction.
- Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction.
- Pulmonary dysfunction.
- Sepsis.
- Known disorder of lipoprotein metabolism or clearance.
- Patients with the following prior conditions are excluded:
- History of allergic or hypersensitivity reactions to light, egg proteins or egg yolks, history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- Excluded within 7 days of therapy:
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Univ of Southern California / Los Angeles
Los Angeles, California, 90033, United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
Univ of California / San Francisco / Dermatology
San Francisco, California, 94143, United States
Health One - Rocky Mountain Cancer Ctr
Denver, Colorado, 80218, United States
Buffalo Gen Hosp / PDT Ctr
Buffalo, New York, 14203, United States
Thompson Cancer Survival Ctr
Knoxville, Tennessee, 37916, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-04