Clinical trial NCT00002167: Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
Official title: Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Skin Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Photochemotherapy
tin etiopurpurin
Radiation-Sensitizing Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ of Southern California / Los Angeles
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Med Ctr
state: California
city: San Francisco
country: United States
facility: Univ of California / San Francisco / Dermatology
state: California
city: Denver
country: United States
facility: Health One - Rocky Mountain Cancer Ctr
state: Colorado
city: Buffalo
country: United States
facility: Buffalo Gen Hosp / PDT Ctr
state: New York
city: Knoxville
country: United States
facility: Thompson Cancer Survival Ctr
state: Tennessee
Study officials:
References: