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


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

261A

NCT ID:

NCT00002167

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Skin Neoplasms
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Photochemotherapy
  • tin etiopurpurin
  • Radiation-Sensitizing Agents
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

Cedars Sinai Med CtrLos Angeles, California  90048
Univ of Southern California / Los AngelesLos Angeles, California  90033
Univ of California / San Francisco / DermatologySan Francisco, California  94143
Health One - Rocky Mountain Cancer CtrDenver, Colorado  80218
Buffalo Gen Hosp / PDT CtrBuffalo, New York  14203
Thompson Cancer Survival CtrKnoxville, Tennessee  37916