Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
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ClinicalTrials.gov Identifier: NCT00002167 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Tin ethyl etiopurpurin | Phase 2 |
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. |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002167
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 |
ClinicalTrials.gov Identifier: | NCT00002167 History of Changes |
Other Study ID Numbers: |
261A |
First Posted: | August 31, 2001 Key Record Dates |
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 |