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


Phase 1
N/A
N/A
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

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


Earlier, the patient gave us blood to make 14g2a chimeric receptor-T cells and 14g2a
chimeric receptor-EBV CTLs in the laboratory. These cells were grown and frozen for the
patient. The patient received treatment with these cells. However, there are enough cells
remaining that we are able to offer to treat the patient with an additional dose if they
would like.

As with the original treatment, the patient will be given an injection of cells into the
vein through and IV. Before the injection is received, the patient will be given a dose of
Benadryl and Tylenol. The injection will take about 2 minutes. We will follow the patient in
the clinic after the injection for 3 hours. The treatment will be given by the Center for
Cell and Gene Therapy at Texas Children's Hospital.

Medical tests before treatment--

Before being treated, the patient will receive a series of standard medical tests:

- Physical exam

- Blood tests to measure blood cells, kidney and liver function

- Measurements of tumor by scans and bone marrow studies if the bone marrow may show
evidence of disease

Medical tests during and after treatment:

The patient will receive standard medical tests when they are getting the infusions and
after:

- Physical exams

- Blood tests to measure blood cells, kidney and liver function

- Measurements of tumor by scans and bone marrow studies if the bone marrow had evidence
of disease 6 weeks after each infusion

Because the patient has received cells with a new gene in them the patient will be followed
for a total of 15 years to see if there are any long term side effects of gene transfer. If
they have a procedure related to their tumor (for example a biopsy or tumor resection), we
will request permission to obtain a tissue sample. This will help investigators learn more
about T cell and CTL treatment of neuroblastoma. In the event of death, we will request
permission to perform an autopsy to learn more about the effects of these infusions on the
disease.


Inclusion Criteria:



High risk neuroblastoma with a history of persistent or relapsed disease, or after initial
therapy

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 6 weeks

Patients must have an ANC > 500, platelet count > 20,000

Patients who have received prior therapy with murine antibodies must have documentation of
absence of human anti-mouse antibodies (HAMA) prior to enrollment on this study

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

Patient may not have cardiomegaly or bilateral pulmonary infiltrates on chest radiograph.
Patients may have pulmonary metastatic lesions

Patient may not have an oxygen requirement as defined by pulse oximetry of > 90% on room
air

Patients must have Karnofsky score of > 60% if > 10 years old or Lansky performance score
of greater than 60% if 10 years old or younger

Patients must have autologous transduced EBV-specific CTLs and transduced peripheral blood
T-cells with 15% expression or greater 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

Patients must not have a history of hypersensitivity to murine protein-containing products

Patients must not have a known sensitivity to rat monoclonal antibodies

Note: All labs must be collected within 10 days prior to initiation of study related
treatment

Exclusion Criteria:

- Patients not meeting eligibility criteria

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety of escalating doses of 14g2a.zeta chimeric receptor transduced autologous EBV CTLs and 14g2a.zeta transduced autologous peripheral blood T-cells in pts with neuroblastoma who were lymphodepleted by CD45 monoclonal antibodies (MAbs).

Outcome Time Frame:

15 yrs

Safety Issue:

Yes

Principal Investigator

Chrystal U Louis, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

13149-NESTLES

NCT ID:

NCT00085930

Start Date:

April 2003

Completion Date:

December 2021

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma
  • Neuroblastoma

Name

Location

Texas Children's HospitalHouston, Texas