Status:
COMPLETED
Immunization Against Tumor Cells in Sezary Syndrome
Lead Sponsor:
University of Pittsburgh
Conditions:
Cutaneous T-cell Lymphoma
Sezary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research is being done to look at the safety and value of a vaccine for a cancer found in the blood and skin known as Cutaneous T-cell lymphoma (CTCL) and Sezary Syndrome. In the laboratory, res...
Detailed Description
Although the etiology of CTCL is not completely understood, immunologic factors appear to play an important role. Dendritic Cell (DC)-tumor cell vaccines have several features that suggest applicatio...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of Sezary syndrome
- Must be willing to discontinue concomitant medications for CTCL, including: \*Oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency, \*PUVA or UVB - 2 week washout, sunbathing, tanning beds, etc. and for the duration of the study, \*Electron Beam - for the duration of the study, \*Chemotherapeutic agents - 30 day washout, \*Bexarotene capsules or other oral biologics - 3 week washout, \*Topical nitrogen mustard - 2 week washout, \*Extracorporeal photopheresis - 4 week washout and for the duration of the study.
- Must be at least 18 years of age and must be able to understand the written informed consent.
- Subjects must have no evidence of active infection. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for continuation of therapy after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment.
Exclusion
- Subjects with autoimmune disease, HIV, and/or hepatitis
- Subjects who are pregnant or lactating
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00099593
Start Date
September 1 2004
End Date
September 1 2007
Last Update
March 25 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center, Department of Dermatology
Pittsburgh, Pennsylvania, United States, 15213