A Combined Cell Therapy Approach to the Treatment of Neuroblastoma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 4/21/2016 |
| Start Date: | April 2016 |
| End Date: | May 2020 |
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.
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.
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.
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.
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.
We found this trial at
1
site
St. Petersburg, Florida 33701
Principal Investigator: Gregory Hale, M.D.
Phone: 727-767-4178
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