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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Solutions
• Treatments: Tin etiopurpurin

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.