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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006100
• Other study ID #: CDR0000068109
• Secondary ID: PSCI-2003-257UAB
• Status: Active, not recruiting
• Phase: Phase 1
• First received: August 3, 2000
• Last updated: December 17, 2013
• Start date: April 2000

Study information

• Verified date: May 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• aldesleukin

• allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes

Drug:
• fludarabine phosphate

Procedure:
• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation