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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Recruitment Status : Withdrawn (no enrollment)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
Sponsor:
Collaborator:
Johns Hopkins All Children's Hospital
Information provided by (Responsible Party):
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Johns Hopkins All Children's Hospital
Investigators
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

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02745756     History of Changes
Other Study ID Numbers: MCC-17181
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Children
Cancer
High-risk neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Vaccines
Keyhole-limpet hemocyanin
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic