Giving Gene Marked EBV Specific T-Cells to Patients Receiving a BMT for Relapsed EBV-Positive Hodgkin Disease

NCT00058773 | Terminated Phase 1 DMC

• 2 other identifiers: H-6422-ANGELAANGELA
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has come back or not gone away after treatment, including the best treatment we know for relapsed Lymphoma. We are asking subjects to volunteer to be in a research study using Epstein Barr virus (EBV) specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation. Some patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are able to hide from the body's immune system and escape destruction. We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells and give them back to subjects.

Conditions

Hodgkin Disease; Non-Hodgkins Lymphoma

Keywords

Hodgkin disease; non-Hodgkins Lymphoma; bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes

  The two injections will be given at day 0 and day 14. Three patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity.

  8 weeks

Secondary Outcomes (1)

• determine the survival, immunological efficacy and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.

  1 year

Study Arms (1)

CTL Administration

EXPERIMENTAL

Infusion of EBV Specific Cytotoxic T-Lymphocytes

Drug: Infusion of EBV Specific Cytotoxic T-Lymphocytes

Interventions

Infusion of EBV Specific Cytotoxic T-Lymphocytes DRUG

EBV specific cytotoxic T-lymphocytes will be given by intravenous injection over 1-10 minutes. Each patient will receive two injections, 14 days apart.

CTL Administration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with Hodgkin disease or non-Hodgkin Lymphoma, containing the EBV genome or antigen, receiving an autologous bone marrow transplant regardless of age or sex.
• Patients with tumor tissue EBV +ve.
• Patients with life expectancy \>6 weeks.
• Patients with Karnofsky score of \> 50.
• No severe intercurrent infection.
• Patient, parent/guardian able to give informed consent.
• Patient with Bilirubin \<2x normal, SGOT \<3x normal, and ANC greater than 500mm
• Patients with creatinine \<2x normal for age or creatinine clearance \>2x normal for age.
• Patients should have been off other investigational therapy for one month prior to entry in this study.

You may not qualify if:

• Patients with a life expectancy of \<6 weeks.
• Patients with an EBV positive Lymphoma secondary to an acquired or congenital immunodeficiency.
• Patients with a Karnofsky score less than or equal to 50.
• Patients with a severe intercurrent infection.
• Patients with a bilirubin \>2x normal,SGOT \>3x normal, or abnormal prothrombin time.
• Patients with a creatinine \>2x normal for age or creatinine clearance \<2x normal for age.
• Patients with an ANC \<500mm
• Patient, parent/guardian unable to give informed consent.
• Patients who have been on other investigational therapy within one month prior to entry in this study.
• Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. Women of childbearing potential must be on appropriate birth control for the duration of the study and 6 months after completion of the study. In addition, the male partner should use a condom.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Catherine Bollard, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 11, 2003
• First Posted: April 15, 2003
• Study Start: January 1, 1996
• Primary Completion: April 1, 2002
• Study Completion: August 1, 2006
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

US (2)