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Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat - Article


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Ear, Nose, And Throat Conditions

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Clinical Trial: Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Cancer of the Nose and Throat

This study is currently recruiting patients.

Sponsors and Collaborators: Baylor College of Medicine
Texas Children's Hospital
The Methodist Hospital
Information provided by: Baylor College of Medicine

Purpose

Most patients with nasopharyngeal cancer (NPC) show evidence of infection with the virus that causes infectious mononucleosis, Epstein Barr virus (EBV) before or at the time of diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with nasopharyngeal cancer suggesting that it may play a role in causing this cancer. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells called T cells that have been trained to kill EBV infected cells can survive in your blood and affect the tumor.

Condition Treatment or Intervention Phase
Nasopharyngeal Cancer
Epstein-Barr Virus Infections
 Vaccine: EBV specific cytotoxic T-lymphocytes
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Head and Neck Cancer;   Throat Disorders;   Viral Infections

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title: Administration of EBV-Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Nasopharyngeal Carcinoma

Further Study Details: 

Expected Total Enrollment:  18

Study start: June 2001

The primary objective of the study is to determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes (CTLs).

The following dose levels will be evaluated:

  • 2x10 7 cells/m2
  • 1x10 8 cells/m2
  • 2x 10 8 cells/m2

Three different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule.

Each patient will receive two injections, 14 days apart, according to the following dosing schedules:

Group One

  • Day 0 - 2x10 7 cells/m2
  • Day 14 - 2x10 7 cells/m2

Group Two

  • Day 0 - 2x10 7 cells/m2
  • Day 14 - 1x10 8 cells/m2

Group Three

  • Day 0 - 1x10 8 cells/m2
  • Day 14 - 2x 10 8 cells/m2

If patients with active disease have stable disease or a partial response by the RECIST criteria at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals, each of which will consist of the same cell number as their second injection. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second injection.

Eligibility

Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

  • All patients with NPC in first or subsequent relapse or with primary refractory disease or high risk (T3 or T4, or node positive disease) in whom the EBV genome or antigens have been demonstrated in tissue biopsies will be eligible for this trial.
  • Patients with a life expectancy >6 weeks
  • Patients with a Karnofsky score of >/= 50
  • No severe intercurrent infection.
  • Patient, parent/guardian able to give informed consent.
  • Patients with bilirubin <2x normal, SGOT <3x normal, and Hgb >8.0
  • Patients with a creatinine <2x normal for age
  • Patients should have been off other investigational therapy for one month prior to entry in this study.

Exclusion criteria:

  • Patients with a life expectancy of <6 weeks.
  • Patients with a Karnofsky score of < 50.
  • Patients with a severe intercurrent infection.
  • Patient, parent/guardian unable to give informed consent.
  • Patients with a bilirubin >2x normal. SGOT >3x normal or abnormal prothrombin time.
  • Patients with a creatinine >2x normal for age
  • Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.

Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigators discretion after approval by the CAGT Protocol Review Committee and the FDA reviewer.


Location and Contact Information


Texas
      The Methodist Hospital, Houston,  Texas,  United States; Recruiting
Helen E Heslop, MD  832-824-4662    hheslop@bcm.tmc.edu 

      Texas Children's Hospital, Houston,  Texas,  United States; Recruiting
Helen E Heslop, MD  832-824-4662    hheslop@bcm.tmc.edu 

Study chairs or principal investigators

Malcolm K Brenner, MD,  Study Chair,  Baylor College of Medicine   

More Information

Study ID Numbers:  9935; NPC
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  December 16, 2003
ClinicalTrials.gov Identifier:  NCT00074594
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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Page Updated: September 6, 2005
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