Clinical trial NCT02745756: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Neuroblastoma
Neoplasms, Nerve Tissue
Keywords: Children
Cancer
High-risk neuroblastoma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Johns Hopkins All Children's Hospital
First posted: 2016-04-20
Enrollment: 0
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Occurrence of Sufficient Tumor Cell Lysate and Dendritic Cells
timeFrame: Up to 1 year
Secondary outcomes:
measure: Occurrence of Dendritic Cell Related Adverse Events
timeFrame: Up to 1 year
Other outcomes:
measure: Rate of Anti-tumor Effect
timeFrame: Up to 1 year
Locations:
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Shari Pilon-Thomas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins All Children's Hospital
name: Gregory Hale, M.D.
role: PRINCIPAL_INVESTIGATOR
References: