A Combined Cell Therapy Approach to the Treatment of Neuroblastoma

NCT02745756 | Withdrawn Phase 1

• 1 other identifier: MCC-17181
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuroblastoma; Neoplasms, Nerve Tissue

Keywords

Children; Cancer; High-risk neuroblastoma

Outcome Measures

Primary Outcomes (1)

• 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?

  Up to 1 year

Secondary Outcomes (1)

• Occurrence of Dendritic Cell Related Adverse Events

  Up to 1 year

Other Outcomes (1)

• Rate of Anti-tumor Effect

  Up to 1 year

Study Arms (1)

Combined Cell Therapy

EXPERIMENTAL

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; Biological: KLH and Tumor Lysate Pulsed DC Vaccine

Interventions

Autologous Hematopoietic Progenitor Cell Transplant PROCEDURE

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.

Also known as: stem cell transplant

Combined Cell Therapy

KLH and Tumor Lysate Pulsed DC Vaccine BIOLOGICAL

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.

Also known as: Dendritic Cell (DC) Vaccine

Combined Cell Therapy

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not an eligible candidate for collection by apheresis or HPC transplant.
• History of autoimmune disorder or immune deficiency disorder.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Johns Hopkins All Children's Hospital: collaborator

MeSH Terms

Conditions

Neuroblastoma; Neoplasms, Nerve Tissue; Neoplasms

Interventions

Stem Cell Transplantation; keyhole-limpet hemocyanin; Vaccines

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Biological Products; Complex Mixtures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: April 14, 2016
• Primary Completion: August 21, 2017
• Study Completion: August 21, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08