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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006100
Enrollment
Unknown
Registered
2003-01-27
Start date
2000-04-30
Completion date
Unknown
Last updated
2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

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.

Interventions

PROCEDUREperipheral blood stem cell transplantation
BIOLOGICALaldesleukin
DRUGfludarabine phosphate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026