Status:
COMPLETED
Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
Patients have high-risk neuroblastoma, a form of cancer typically found in children. The patients previously participated in a gene transfer research study using special immune cells. This research st...
Detailed Description
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 receiv...
Eligibility Criteria
Inclusion
- 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
- Patients not meeting eligibility criteria
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00085930
Start Date
April 1 2003
End Date
August 1 2025
Last Update
January 7 2026
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030