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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002167
• Other study ID #: 261A
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Tin ethyl etiopurpurin

Locations

Country	Name	City	State
United States	Buffalo Gen Hosp / PDT Ctr	Buffalo	New York
United States	Health One - Rocky Mountain Cancer Ctr	Denver	Colorado
United States	Thompson Cancer Survival Ctr	Knoxville	Tennessee
United States	Cedars Sinai Med Ctr	Los Angeles	California
United States	Univ of Southern California / Los Angeles	Los Angeles	California
United States	Univ of California / San Francisco / Dermatology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Solutions

Country where clinical trial is conducted

United States,