A Combined Cell Therapy Approach to the Treatment of Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT02745756|
Recruitment Status : Withdrawn (no enrollment)
First Posted : April 20, 2016
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Neoplasms, Nerve Tissue||Procedure: Autologous Hematopoietic Progenitor Cell Transplant Biological: KLH and Tumor Lysate Pulsed DC Vaccine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Combined Cell Therapy Approach to the Treatment of Neuroblastoma|
|Actual Study Start Date :||April 14, 2016|
|Actual Primary Completion Date :||August 21, 2017|
|Actual Study Completion Date :||August 21, 2017|
Experimental: Combined Cell Therapy
Hematopoietic progenitor cell (HPC) transplant (HPCT) with autologous tumor cell lysate and keyhole limpet hemocyanin (KLH) pulsed dendritic cell (DC) vaccine.
Procedure: Autologous Hematopoietic Progenitor Cell Transplant
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.
Other Name: stem cell transplant
Biological: KLH and Tumor Lysate Pulsed DC Vaccine
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.
Other Name: Dendritic Cell (DC) Vaccine
- Occurrence of Sufficient Tumor Cell Lysate and Dendritic Cells [ Time Frame: Up to 1 year ]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?
- Occurrence of Dendritic Cell Related Adverse Events [ Time Frame: Up to 1 year ]Toxicities resulting from the administration of dendritic cell vaccines in the immediate post hematopoietic cell graft period.
- Rate of Anti-tumor Effect [ Time Frame: Up to 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745756
|Principal Investigator:||Shari Pilon-Thomas, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|
|Principal Investigator:||Gregory Hale, M.D.||Johns Hopkins All Children's Hospital|