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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
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Southern California / Los Angeles
Los Angeles, California, United States, 90033
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002167     History of Changes
Other Study ID Numbers: 261A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Sarcoma
Sarcoma, Kaposi
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Tin etiopurpurin
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014