NCT00006100

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.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

May 1, 2005

First QC Date

August 3, 2000

Last Update Submit

December 17, 2013

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Interventions

aldesleukinBIOLOGICAL
allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytesBIOLOGICAL
fludarabine phosphateDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Related 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. doi: 10.1002/cncr.20188.

    PMID: 15112270RESULT

MeSH Terms

Conditions

LymphomaHodgkin Disease

Interventions

aldesleukinfludarabine phosphatePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Hematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Kenneth G. Lucas, MD

    Milton S. Hershey Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Last Updated

December 18, 2013

Record last verified: 2005-05

Locations

US(1)