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

Study Description

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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 Design

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Study Type :	Interventional (Clinical Trial)
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.

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00002167 History of Changes
Other Study ID Numbers:	261A
First Posted:	August 31, 2001
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	Photochemotherapy; tin etiopurpurin; Radiation-Sensitizing Agents

Additional relevant MeSH terms:

HIV Infections; Sarcoma; 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; Neoplasms; Herpesviridae Infections; DNA Virus Infections; Neoplasms, Vascular Tissue; Tin etiopurpurin; Photosensitizing Agents; Dermatologic Agents