A Combined Cell Therapy Approach to the Treatment of Neuroblastoma

Phase 1

Withdrawn

• Conditions: Neoplasms, Nerve Tissue; Neuroblastoma
• Interventions: Procedure: Autologous Hematopoietic Progenitor Cell Transplant; Biological: KLH and Tumor Lysate Pulsed DC Vaccine

• Registration Number: NCT02745756
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Timeline

• Study Start: 2016-04-14
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-20
• Status Verified: 2017-08
• Primary Completion: 2017-08-21
• Study Completion: 2017-08-21
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined Cell Therapy	KLH and Tumor Lysate Pulsed DC Vaccine	Hematopoietic progenitor cell (HPC) transplant (HPCT) with autologous tumor cell lysate and keyhole limpet hemocyanin (KLH) pulsed dendritic cell (DC) vaccine.
Combined Cell Therapy	Autologous Hematopoietic Progenitor Cell Transplant	Hematopoietic progenitor cell (HPC) transplant (HPCT) with autologous tumor cell lysate and keyhole limpet hemocyanin (KLH) pulsed dendritic cell (DC) vaccine.

Primary Outcome Measures

Name	Time	Method
Occurrence of Sufficient Tumor Cell Lysate and Dendritic Cells	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?

Secondary Outcome Measures

Name	Time	Method
Occurrence of Dendritic Cell Related Adverse Events	Up to 1 year	Toxicities resulting from the administration of dendritic cell vaccines in the immediate post hematopoietic cell graft period.