- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00085930
Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients (NESTLES)
Administration of Peripheral Blood T-Cells and EBV Specific CTLs Transduced to Express GD-2 Specific Chimeric T Cell Receptors to Patients With Neuroblastoma
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
CTLs: 2x10e7 cells/m2
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the safety of 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
Time Frame: 15 yrs
|
Listings of adverse events by patients will include the time to onset, the duration of each event, the severity of each event, and the relationship of the event to study therapy, whether it was a serious event, and whether it caused withdrawal.
|
15 yrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the differential survival and function of these two infused cell-types in vivo, in particular to determine if chimeric receptor transduced EBV-CTLs survive longer than transduced peripheral-blood T-cells.
Time Frame: 15 yrs
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To compare the in vivo survival and expansion of the T cells and the CTL and to determine if the T cells or the CTL expand more rapidly after infusion.
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15 yrs
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Determine anti-tumor effects of transduced peripheral blood T-cells and EBV specific CTLs in vivo.
Time Frame: 15 years
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Frequencies and proportions of anti-tumor activity based on evaluations of tumor size.
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15 years
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Compare the differential survival of these infused cells in an additional 6 patients treated at dose level #1 without CD45 antibody mediated lymphodepletion, to patients previously treated at dose levels #2 and #3.
Time Frame: 15 years
|
Detect a 1-week half-life difference between dose level 1 and dose level 2
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15 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andras A Heczey, MD, Baylor College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13149-NESTLES
- NESTLES (Other Identifier: BCM CAGT)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuroblastoma
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Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage 4S Neuroblastoma | Ganglioneuroblastoma | Stage 2A Neuroblastoma | Stage 2B Neuroblastoma | Stage 3 Neuroblastoma | Stage 4 Neuroblastoma | Stage 1 Neuroblastoma | Stage 2 NeuroblastomaUnited States, Canada, Australia, New Zealand
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Neuroblastoma | Disseminated Neuroblastoma | Localized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4S NeuroblastomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingLocalized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4S Neuroblastoma | Ganglioneuroblastoma | Stage 4 NeuroblastomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingRecurrent Neuroblastoma | Stage 4S Neuroblastoma | Stage 2A Neuroblastoma | Stage 2B Neuroblastoma | Stage 3 Neuroblastoma | Stage 4 NeuroblastomaUnited States, Canada, Australia, New Zealand
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Neuroblastoma | Localized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4S Neuroblastoma | Stage 4 NeuroblastomaUnited States, Canada, Australia, New Zealand, Puerto Rico
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Neuroblastoma | Localized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4S Neuroblastoma | Stage 4 NeuroblastomaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingLocalized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4S Neuroblastoma | Ganglioneuroblastoma | Stage 4 NeuroblastomaUnited States, Puerto Rico, Canada, Australia, New Zealand, Netherlands, Saudi Arabia, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedLocalized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4S NeuroblastomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Neuroblastoma | Localized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4 NeuroblastomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Neuroblastoma | Disseminated Neuroblastoma | Localized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Stage 4S NeuroblastomaUnited States
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