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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002167
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Sarcoma, Kaposi HIV Infections Drug: Tin ethyl etiopurpurin Phase 2

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  (Clinical Trial)
Estimated Enrollment : 78 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002167

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

ClinicalTrials.gov Identifier: NCT00002167     History of Changes
Other Study ID Numbers: 261A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
tin etiopurpurin
Radiation-Sensitizing Agents

Additional relevant MeSH terms:
HIV Infections
Sarcoma, Kaposi
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Tin etiopurpurin
Photosensitizing Agents
Dermatologic Agents