Back to resultsA Combined Cell Therapy Approach to the Treatment of Neuroblastoma
Primary Purpose
Neuroblastoma, Neoplasms, Nerve Tissue
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Autologous Hematopoietic Progenitor Cell Transplant
KLH and Tumor Lysate Pulsed DC Vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring Children, Cancer, High-risk neuroblastoma
Eligibility Criteria
Inclusion Criteria:
- Must have a histological diagnosis of neuroblastoma or ganglioneuroblastoma and be either newly diagnosed with high risk disease or have failed previous treatment: Patients who have failed previous treatment may have had no more than one earlier autologous HPC transplant.
- Participant is expected to undergo autologous HPC transplantation that is consistent with standard of care.
- Must have the presence of residual resectable disease for which surgery is clinically indicated, and will be performed at Johns Hopkins All Children's Hospital.
Exclusion Criteria:
- Not an eligible candidate for collection by apheresis or HPC transplant.
- History of autoimmune disorder or immune deficiency disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combined Cell Therapy
Arm Description
Hematopoietic progenitor cell (HPC) transplant (HPCT) with autologous tumor cell lysate and keyhole limpet hemocyanin (KLH) pulsed dendritic cell (DC) vaccine.
Outcomes
Primary Outcome Measures
Occurrence of Sufficient Tumor Cell Lysate and Dendritic Cells
The feasibility of manufacturing both a hematopoietic progenitor cell graft and multiple tumor lysate pulsed dendritic cell vaccine treatments from the same starting apheresis product, culminating in delivery of the vaccines in the immediate period following myeloablative therapy and autologous hematopoietic progenitor cell transplant period (autoHPCT). For what fraction of eligible patients can sufficient tumor cell lysate and dendritic cells, necessary for the production of the dendritic cell vaccines, be obtained? From what fraction would it be possible to make additional vaccines?
Secondary Outcome Measures
Occurrence of Dendritic Cell Related Adverse Events
Toxicities resulting from the administration of dendritic cell vaccines in the immediate post hematopoietic cell graft period.
Full Information
NCT ID
NCT02745756
First Posted
April 18, 2016
Last Updated
August 29, 2017
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Johns Hopkins All Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02745756
Brief Title
A Combined Cell Therapy Approach to the Treatment of Neuroblastoma
Official Title
A Combined Cell Therapy Approach to the Treatment of Neuroblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
August 21, 2017 (Actual)
Study Completion Date
August 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Johns Hopkins All Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study adds an experimental treatment with another type of cells, called dendritic cells. It is hoped that these cells may stimulate the immune system to react against neuroblastoma in much the same way that vaccines cause the immune system to react to certain viruses and bacteria. The physicians conducting this study have observed from previous research that neuroblastoma cells can be recognized by the immune system, and that they can be destroyed by immune cells.The main goal of this study is to see if giving participants this additional anti-Neuroblastoma vaccine reduces the risk of relapse following the Hematopoietic Stem Cell Transplant.
Detailed Description
All patients who are enrolled in this study will receive all treatment at All Children's Hospital which is located at 501 6th Ave South, St. Petersburg, FL 33701. This includes autologous cell donation by apheresis, high dose cytotoxic therapy conditioning for autologous HPC transplant, post-transplant follow-up care, and all administration of dendritic cell vaccines and blood draws for post therapy immunological monitoring.
All preparation of cellular products, including hematopoietic progenitor cell products for autologous transplantation, and dendritic cell vaccine products, will be carried out in the Cell Therapy Facility located within the Moffitt Cancer Center, which is located at 12902 Magnolia Drive, Tampa, FL 33612.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Neoplasms, Nerve Tissue
Keywords
Children, Cancer, High-risk neuroblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined Cell Therapy
Arm Type
Experimental
Arm Description
Hematopoietic progenitor cell (HPC) transplant (HPCT) with autologous tumor cell lysate and keyhole limpet hemocyanin (KLH) pulsed dendritic cell (DC) vaccine.
Intervention Type
Procedure
Intervention Name(s)
Autologous Hematopoietic Progenitor Cell Transplant
Other Intervention Name(s)
stem cell transplant
Intervention Description
Autologous Hematopoietic Progenitor Cell (HPC) Transplant (HPCT). Blood stem cells will be collected by apheresis during the induction phase as part of standard treatment. During apheresis, the participant's blood is collected into a machine that filters out the stem cells and the filtered blood is returned to their body. The stem cells will be separated by the type of protein within the cells. Only the stem cells with a protein called CD34 will be used for the stem cell transplant.
Intervention Type
Biological
Intervention Name(s)
KLH and Tumor Lysate Pulsed DC Vaccine
Other Intervention Name(s)
Dendritic Cell (DC) Vaccine
Intervention Description
Keyhole limpet hemocyanin (KLH) pulsed dendritic cell (DC) vaccine. Post-transplant vaccine days: +14, +28, +56 (± 10 days), +84 (± 10 days). Vaccines will be administered by intradermal injection of 0.5 mL at two nodal basins.
Primary Outcome Measure Information:
Title
Occurrence of Sufficient Tumor Cell Lysate and Dendritic Cells
Description
The feasibility of manufacturing both a hematopoietic progenitor cell graft and multiple tumor lysate pulsed dendritic cell vaccine treatments from the same starting apheresis product, culminating in delivery of the vaccines in the immediate period following myeloablative therapy and autologous hematopoietic progenitor cell transplant period (autoHPCT). For what fraction of eligible patients can sufficient tumor cell lysate and dendritic cells, necessary for the production of the dendritic cell vaccines, be obtained? From what fraction would it be possible to make additional vaccines?
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Occurrence of Dendritic Cell Related Adverse Events
Description
Toxicities resulting from the administration of dendritic cell vaccines in the immediate post hematopoietic cell graft period.
Time Frame
Up to 1 year
Other Pre-specified Outcome Measures:
Title
Rate of Anti-tumor Effect
Description
Whether a discernable anti-tumor effect resulting from autoHPCT therapy combined with dendritic cell vaccine therapy can be detected, either through monitoring of the patient's immune system for evidence of tumor specific immunity, or by monitoring for measureable clinical responses.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have a histological diagnosis of neuroblastoma or ganglioneuroblastoma and be either newly diagnosed with high risk disease or have failed previous treatment: Patients who have failed previous treatment may have had no more than one earlier autologous HPC transplant.
Participant is expected to undergo autologous HPC transplantation that is consistent with standard of care.
Must have the presence of residual resectable disease for which surgery is clinically indicated, and will be performed at Johns Hopkins All Children's Hospital.
Exclusion Criteria:
Not an eligible candidate for collection by apheresis or HPC transplant.
History of autoimmune disorder or immune deficiency disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari Pilon-Thomas, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory Hale, M.D.
Organizational Affiliation
Johns Hopkins All Children's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Combined Cell Therapy Approach to the Treatment of Neuroblastoma
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