RATIONALE: Vaccines made from cancer cells that have the Epstein-Barr virus may make the body build an immune response to and kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of Epstein-Barr virus-specific cytotoxic T cells in treating patients with relapsed Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
recurrent adult Hodgkin's lymphoma recurrent/refractory childhood Hodgkin's lymphoma	Drug: EBV-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 feasibility of generating Epstein-Barr virus (EBV)-specific cytotoxic T-cell lines from patients with active Hodgkin's lymphoma or Hodgkin's lymphoma in remission.
• Determine the safety of two intravenous injections of autologous EBV-specific cytotoxic T-lymphocytes marked with the neomycin resistance gene introduced by a retroviral vector.
• Determine the immunological efficacy, antitumor effects, and survival associated with this regimen.

OUTLINE: This is a dose escalation study.

Patients receive 2 intravenous injections given 2 weeks apart of Epstein-Barr virus-specific autologous cytotoxic T-lymphocytes that have been marked with the neomycin resistance gene introduced by a retroviral vector.

Cohorts of 3-6 patients receive escalating doses of cells until the maximum tolerated dose is determined.

Patients are followed at 2, 4, and 6 weeks, then monthly for 1 year, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study within 1.5 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Hodgkin's lymphoma of any histologic subtype in 1 of the following categories:
• In second or subsequent relapse OR
• In first relapse and immunosuppressive chemotherapy contraindicated, e.g., Hodgkin's lymphoma developing after solid organ transplant
• Epstein-Barr virus genome or antigens demonstrated in tissue biopsy

PATIENT CHARACTERISTICS: Age:

• Any age

Performance status:

• Karnofsky 50-100%

Life expectancy:

• Greater than 6 weeks

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than twice normal
• AST less than 3 times normal
• PT normal

Renal:

• Creatinine less than twice normal for age OR
• Creatinine clearance greater than twice normal for age

Other:

• No severe concurrent infection

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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:  CDR0000064990; BCM-ANGEL-6423; BCM-ANGEL-6387; SJCRH-ANGEL-6387; NCI-V96-0971; NCT00002821
Record last reviewed:  January 2000
Last Updated:  February 24, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002821
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08