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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002167
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002167 on ClinicalTrials.gov Archive Site
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Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study 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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Tin ethyl etiopurpurin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002167
261A
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Clinical Solutions
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NIH AIDS Clinical Trials Information Service
April 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP