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Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients - Article


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Estrogen Receptors



Clinical Trial: Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients

This study is currently recruiting patients.

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

Purpose

The purpose of this study is to find the biggest dose of antibody-attached T cells that is safe, to see how long each sort of T cell lasts, to learn what the side effects are and to see whether this therapy might help children with neuroblastoma.

Condition Treatment or Intervention Phase
Neuroblastoma
 Gene Transfer: 14g2a
 Gene Transfer: CTLs
Phase I

MedlinePlus related topics:  Neuroblastoma

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

Official Title: Administration of Peripheral Blood T-Cells and EBV Specific CTLs Transduced to Express GD-2 Specific Chimeric T Cell Receptors to Patients with Neuroblastoma

Further Study Details: 

Expected Total Enrollment:  18

Study start: April 2003

PATIENT TREATMENT Three different dose levels will be evaluated. Three to six patients will be evaluated on each level. Each patient will receive two injections, 14 days apart, according to the following dosing schedules:

Group One

  • Day 0 CTLs: 2x10^7 cells/m2 PBMCs: 2x10^7 cells/m2
  • Day 14 CTLs: 2x10^7 cells/m2 PBMCs: 2x10^7 cells/m2

Group Two

  • Day 0 CTLs: 2x10^7 cells/m2 PBMCs: 2x10^7 cells/m2
  • Day 14 CTLs: 1x10^8 cells/m2 PBMCs: 1x10^8 cells/m2

Group Three

  • Day 0 CTLs: 1x10^8 cells/m2 PBMCs: 1x10^8 cells/m2
  • Day 14 CTLs: 1x10^8 cells/m2 PBMCs: 1x10^8 cells/m2

Eligibility

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • All patients with recurrent or refractory advanced stage neuroblastoma.
  • Patients must be EBV sero-positive.
  • Patients must have a life expectancy of at least 12 weeks.
  • Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study.
  • Patients must not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks.
  • Patients must have bilirubin less than 3 times the upper limit of normal.
  • Patients must have AST less than 5 times the upper limit of normal.
  • Patients must have serum creatinine less than 3 times upper limit of normal.
  • Patients must have Karnofsky score of > 60% if >/= 10 years old or Lansky performance score of greater than 60% if /=15% expression of 14g2a.zeta determined by flow-cytometry.
  • Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.
  • Patients must not be pregnant or lactating.
  • Patients must not have tumor in a location where enlargement could cause airway obstruction.

Exclusion Criteria:

  • Patients not meeting eligibility criteria.

Location and Contact Information

Heidi V Russell, MD      832-822-4885    hvrussel@texaschildrenshospital.org

Texas
      Texas Children's Hospital, Houston,  Texas,  77095,  United States; Recruiting
Heidi V Russell  832-822-4885    hvrussel@texaschildrenshospital.org 

Study chairs or principal investigators

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

More Information

Study ID Numbers:  H13149; NESTLES
Record last reviewed:  November 2004
Last Updated:  November 3, 2004
Record first received:  June 17, 2004
ClinicalTrials.gov Identifier:  NCT00085930
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: February 22, 2005
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