- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00099593
Immunization Against Tumor Cells in Sezary Syndrome
Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells
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, researches found that special white blood cells, called dendritic cells (DCs), are able to stimulate the immune system (groups of cells that protect the body from germs and diseases) in a way that helps your body fight cancer. Autologous (from your own body) DCs will be prepared (mixed together) in the laboratory with your cancer cell (Sezary cells) to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Completion date provided represents the completion date of the grant per OOPD records
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center, Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
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Secondary Outcome Measures
Outcome Measure |
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Quality of Life
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Survival
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Activities of daily living
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Biological response
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Larisa J. Geskin, M.D., University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FD-R-002545-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sezary Syndrome
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National Cancer Institute (NCI)Active, not recruitingMycosis Fungoides | Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8 | Recurrent Mycosis Fungoides... and other conditionsUnited States
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Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMycosis Fungoides | Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage III Mycosis Fungoides... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Mycosis Fungoides and Sezary Syndrome | Refractory Mycosis Fungoides and Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIIA Mycosis... and other conditionsUnited States
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Northwestern UniversityAmgenTerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma | Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IA Mycosis Fungoides/Sezary Syndrome | Stage... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Mycosis Fungoides and Sezary Syndrome | Refractory Mycosis Fungoides and Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIIA Mycosis... and other conditionsUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...WithdrawnRecurrent Mycosis Fungoides and Sezary Syndrome | Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage IIB Mycosis Fungoides and Sezary Syndrome | Stage IIIA Mycosis Fungoides and Sezary Syndrome | Stage IIIB Mycosis Fungoides and Sezary Syndrome | Stage IVA Mycosis Fungoides and Sezary Syndrome | Stage...
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City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingSezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Transformed Mycosis Fungoides | Folliculotropic... and other conditionsUnited States
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National Cancer Institute (NCI)RecruitingStage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8United States
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Kevin Cooper MDNational Cancer Institute (NCI)CompletedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IA Mycosis Fungoides/Sezary Syndrome | Stage IB Mycosis Fungoides/Sezary Syndrome | Stage II Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IIA Mycosis...United States
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National Cancer Institute (NCI)TerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage III Mycosis Fungoides/Sezary Syndrome | Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IV Mycosis Fungoides/Sezary Syndrome | Stage I... and other conditionsUnited States
Clinical Trials on Autologous Dendritic Cell Vaccine
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Jan WalewskiCompletedLymphoma | Multiple Myeloma and Plasma Cell NeoplasmPoland
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Radboud University Medical CenterDutch Cancer SocietyCompletedMelanoma Stage III or IVNetherlands
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Maria Sklodowska-Curie National Research Institute...Unknown
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Dana-Farber Cancer InstituteNational Cancer Institute (NCI)UnknownMelanoma (Skin)United States
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Dartmouth-Hitchcock Medical CenterNational Cancer Institute (NCI)CompletedMelanoma (Skin)United States
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Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum...Unknown
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Jonsson Comprehensive Cancer CenterCompletedLung CancerUnited States
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Leo W. Jenkins Cancer CenterH. Lee Moffitt Cancer Center and Research InstituteTerminatedMetastatic Pancreatic CancerUnited States
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Rockefeller UniversityMemorial Sloan Kettering Cancer CenterCompleted
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedMelanoma (Skin)United States