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Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cutaneous T-Cell Lymphoma, Sezary Syndrome

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Trial Information

Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells


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 applications for
the immunotherapy of human tumors. Importantly, DC-tumor cell immunization has the
potential to simultaneously stimulate CD4+ and CD8+ T cell-mediated immunity against
multiple tumor antigens.

The vaccine will be prepared from the subject's own blood, obtained during leukapheresis.
From leukapheresed blood, monocyte-derived DCs and malignant lymphocytes will be isolated.
The DCs will then be loaded with lymphocyte-derived tumor antigens. Formulations and
release criteria must be met before vaccine can be administered.


Inclusion Criteria:



- 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 Criteria:

- Subjects with autoimmune disease, HIV, and/or hepatitis

- Subjects who are pregnant or lactating

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)

Principal Investigator

Larisa J. Geskin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

FD-R-002545-01

NCT ID:

NCT00099593

Start Date:

September 2004

Completion Date:

December 2008

Related Keywords:

  • Cutaneous T-cell Lymphoma
  • Sezary Syndrome
  • Cutaneous T-cell lymphoma (CTCL)
  • Sezary Syndrome
  • Mycosis Fungoides
  • Vaccine
  • Lymphoma
  • Sezary Syndrome
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location
University of Pittsburgh Medical Center, Department of Dermatology Pittsburgh, Pennsylvania  15213