Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients (NESTLES)
Neuroblastoma
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring Neuroblastoma
Eligibility Criteria
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
Sites / Locations
- Texas Children's Hospital
Arms of the Study
Arm 1
Experimental
EBV specific CTLs w/out lymphodepletion
Escalating doses of 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) and 14g2a.zeta transduced autologous peripheral blood T-cells administered to patients with Neuroblastoma.