search
Back to results

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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tin ethyl etiopurpurin
Sponsored by
Clinical Solutions
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Photochemotherapy, tin etiopurpurin, Radiation-Sensitizing Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Southern California / Los Angeles
  • Cedars Sinai Med Ctr
  • Univ of California / San Francisco / Dermatology
  • Health One - Rocky Mountain Cancer Ctr
  • Buffalo Gen Hosp / PDT Ctr
  • Thompson Cancer Survival Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Clinical Solutions
search

1. Study Identification

Unique Protocol Identification Number
NCT00002167
Brief Title
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

2. Study Status

Record Verification Date
April 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Clinical Solutions

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Photochemotherapy, tin etiopurpurin, Radiation-Sensitizing Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
78 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tin ethyl etiopurpurin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Univ of Southern California / Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Univ of California / San Francisco / Dermatology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Health One - Rocky Mountain Cancer Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Buffalo Gen Hosp / PDT Ctr
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Thompson Cancer Survival Ctr
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs