NESTLESAdministration of Peripheral Blood T-Cells and EBV Specific CTLs Transduced to Express GD-2 Specific Chimeric T Cell Receptors to Patients with Neuroblastoma
EBV specific CTLs
Néoplasmes germinaux et embryonnaires+7
+ Néoplasmes par type histologique
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2003
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.19 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 21 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site