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

This study has been completed.

Sponsored by: Clinical Solutions
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002167
  Purpose

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 Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Tin ethyl etiopurpurin
Phase II

MedlinePlus related topics:   AIDS    Cancer    Kaposi's Sarcoma    Soft Tissue Sarcoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Parallel Assignment, Safety Study
Official Title:   Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   78

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002167

Locations
United States, California
Cedars Sinai Med Ctr    
      Los Angeles, California, United States, 90048
Univ of California / San Francisco / Dermatology    
      San Francisco, California, United States, 94143
Univ of Southern California / Los Angeles    
      Los Angeles, California, United States, 90033
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
  More Information


Study ID Numbers:   261A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002167
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Skin Neoplasms
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections
Tin etiopurpurin

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Infection
Pharmacologic Actions
Neoplasms
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Lentivirus Infections
Neoplasms, Vascular Tissue
Dermatologic Agents

ClinicalTrials.gov processed this record on September 16, 2008




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