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Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
fludarabine phosphate
peripheral blood stem cell transplantation
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
December 17, 2013
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006100
Brief Title
Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma
Official Title
A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Donor white blood cells that are treated in the laboratory with Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma. 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
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth G. Lucas, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15112270
Citation
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.
Results Reference
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Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma

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