RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's cytotoxic T lymphocytes in the laboratory and reinfusing them may cause a stronger immune response to kill Epstein-Barr virus-associated cancer cells.

PURPOSE: Phase I trial to study the effectiveness of autologous cytotoxic T-lymphocytes in treating patients who have relapsed Epstein-Barr virus-associated Hodgkin's lymphoma or non-Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
recurrent adult Hodgkin's lymphoma recurrent/refractory childhood Hodgkin's lymphoma primary central nervous system lymphoma post-transplant lymphoproliferative disorder	Drug: LMP2A-specific cytotoxic T-lymphocytes  Procedure: biological response modifier therapy  Procedure: leukocyte therapy  Procedure: peripheral blood lymphocyte therapy	Phase I

Further Study Details: 

OBJECTIVES:

• Determine the safety of autologous LMP2A-specific cytotoxic T-lymphocytes in patients with relapsed Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma.
• Determine the survival and immune function of patients treated with this regimen.
• Determine the antiviral and antitumor effects of this regimen in these patients.
• Obtain preliminary information on the safety of and response to an extended dosage of this regimen in these patients.

OUTLINE: Peripheral blood is collected and autologous dendritic cells (DC) are generated over 7 days using sargramostim (GM-CSF) and interleukin-4 (IL-4). DC are transduced with recombinant AdLMP2A and matured with GM-CSF, TNFa, PGE-1, and IL-4 over 2 days to stimulate cytotoxic T-lymphocytes (CTL). Patients receive LMP2A-specific CTL IV over 1-10 minutes on days 0 and 14.

Cohorts of 3-6 patients receive escalating doses of LMP2A-specific CTL.

Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of LMP2A-specific CTL IV over 1-10 minutes once monthly.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma
• Any histological subtype, excluding diffuse small noncleaved cell and Burkitt's lymphoma
• Meets criteria for 1 of the following:
• Second or subsequent relapse (or first relapse if immunosuppressive chemotherapy is contraindicated) (group A)
• In remission OR with minimal residual disease after autologous stem cell transplantation for Hodgkin's or non-Hodgkin's lymphoma (group B)

PATIENT CHARACTERISTICS: Age

• Any age

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 6 weeks

Hematopoietic

• Hemoglobin greater than 8.0 g/dL

Hepatic

• Bilirubin less than 3 times normal
• AST less than 5 times normal

Renal

• Creatinine less than 2 times normal

Other

• Not pregnant
• Fertile patients must use effective contraception
• No concurrent severe infection
• HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 1 month since prior investigational therapy

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

Helen E. Heslop, MD,  Study Chair,  Baylor College of Medicine   

Study ID Numbers:  CDR0000330143; BCM-H-9936; NCT00070226
Record last reviewed:  November 2003
Last Updated:  December 6, 2004
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070226
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08