Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.

June 23, 2005 updated by: Clinical Solutions
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Med Ctr
      • Los Angeles, California, United States, 90033
        • Univ of Southern California / Los Angeles
      • San Francisco, California, United States, 94143
        • Univ of California / San Francisco / Dermatology
    • Colorado
      • Denver, Colorado, United States, 80218
        • Health One - Rocky Mountain Cancer Ctr
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo Gen Hosp / PDT Ctr
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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.

Exclusion Criteria

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:

  • Hematopoietic dysfunction.
  • Coagulation dysfunction.
  • Hepatic dysfunction.
  • Renal dysfunction.

Excluded within 3 months of therapy:

  • Pulmonary dysfunction.

Excluded within 6 months of therapy:

  • Myocardial infarction.

Prior Medication:

Excluded:

  • Intralesional chemotherapy within the past 12 weeks.
  • Systemic chemotherapy or investigational drugs within the past 4 weeks.

Prior Treatment:

Excluded within 3 months prior to therapy:

  • Local cryotherapy or surgery to study lesions.
  • Systemic or topical photodynamic therapy agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Tin ethyl etiopurpurin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe