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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


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth G. Lucas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000068109

NCT ID:

NCT00006100

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850