NESTLESAdditional Dose of Peripheral Blood T-Cells and EBV Specific CTLs for Neuroblastoma Treatment
This study aims to evaluate the safety of increasing doses of 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) and 14g2a.zeta transduced autologous peripheral blood T-cells in the treatment of neuroblastoma, focusing on monitoring any adverse events and their relationship to the study therapy.
EBV specific CTLs
Neoplasms+7
+ Neoplasms by Histologic Type
+ Neoplasms, Germ Cell and Embryonal
Treatment Study
Summary
Study start date: April 1, 2003
Actual date on which the first participant was enrolled.This clinical trial focuses on treating neuroblastoma, a type of cancer that typically affects children. The study uses a special kind of treatment where the patient's own immune cells, called T-cells and EBV Specific CTLs, are modified in the lab to better fight the cancer. These cells are altered to express a specific receptor, known as GD-2 Specific Chimeric T Cell Receptors. The goal is to evaluate the safety and effectiveness of this treatment approach in managing neuroblastoma. The study is important as it could potentially lead to improved treatments for this type of cancer. During the trial, participants will receive an injection of the modified cells into their vein through an IV. Before the injection, they will be given a dose of Benadryl and Tylenol. The injection process will last about 2 minutes, followed by a 3-hour observation period in the clinic. Participants will undergo regular medical tests before, during, and after the treatment. These tests include physical exams, blood tests, and tumor measurements. The purpose of these tests is to monitor the participant's health and to evaluate how well the treatment is working. Participants will be followed for a total of 15 years to assess any long-term side effects of the gene transfer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location