Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma
NCT ID: NCT00006100
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
INTERVENTIONAL
2000-04-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive, relapsed, or refractory Hodgkin's lymphoma.
Detailed Description
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* Determine the toxicity of allogeneic Epstein Barr virus (EBV)-specific cytotoxic T-lymphocytes (EBV CTL) in patients with progressive, relapsed, or refractory EBV-positive Hodgkin's lymphoma.
* Detect alterations in the anti-EBV cellular immunity of patients treated with EBV CTL.
OUTLINE: Donors undergo leukapheresis. Epstein Barr virus-specific cytotoxic T lymphocytes (EBV CTL) are cultured in vitro.
Patients receive an infusion of EBV CTL over 10 minutes on day 0. The EBV CTL infusion is preceded by 3 doses of fludarabine. Patients then receive interleukin-2 injections for 12 days after the EBV CTL infusion.
Patients are followed weekly for 1.5 months, twice a month for 1.5 months, and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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aldesleukin
allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
fludarabine phosphate
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Histologically proven Hodgkin's lymphoma
* Progressive, relapsed, or refractory disease after prior chemotherapy, radiotherapy, and/or stem cell transplantation
* Epstein Barr virus (EBV) positive by immunohistochemical staining for LMP-1 or 2 OR the presence of EBV RNA (EBER)
* Availability of an HLA identical or haploidentical donor for cytotoxic T-lymphocytes, meeting the following criteria:
* EBV seropositive
* HIV negative
* HTLV-1 negative
* Hepatitis B surface antigen and hepatitis B core antibody IgM negative
* Hepatitis C antibody negative
* Must share at least 1 HLA haplotype with donor
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* Not specified
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2.0 mg/dL
* SGOT/SGPT less than 2.5 times normal (unless liver metastases are present)
* If there is liver involvement by disease, an obvious relationship between SGOT/SGPT and disease activity is required
* No hepatic dysfunction causing moribundity
Renal:
* Creatinine clearance greater than 50 mL/min
* No renal dysfunction causing moribundity
Cardiovascular:
* No cardiac dysfunction causing moribundity
Pulmonary:
* No pulmonary dysfunction causing moribundity
Other:
* No neurologic dysfunction causing moribundity
* No history of severe transfusion reactions with blood products (including fetal calf serum)
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* No concurrent antimetabolites
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
Surgery:
* Not specified
18 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Milton S. Hershey Medical Center
OTHER
Principal Investigators
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Kenneth G. Lucas, MD
Role: STUDY_CHAIR
Milton S. Hershey Medical Center
Locations
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Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Lucas KG, Salzman D, Garcia A, Sun Q. Adoptive immunotherapy with allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes for recurrent, EBV-positive Hodgkin disease. Cancer. 2004 May 1;100(9):1892-901. doi: 10.1002/cncr.20188.
Other Identifiers
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PSCI-2003-257
Identifier Type: -
Identifier Source: secondary_id
UAB-0002
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1829
Identifier Type: -
Identifier Source: secondary_id
CDR0000068109
Identifier Type: -
Identifier Source: org_study_id