NB2012: Therapy for Children with Advanced Stage High-Risk Neuroblastoma

Anti-GD2 Monoclonal Antibody Hu14.18K322A and Combination Chemotherapy before Autologous Stem Cell Transplant and Radiation Therapy in Treating Younger Patients with Previously Untreated High-Risk Neuroblastoma

Category:

Solid Tumor

Diseases Treated:

Neuroblastoma

Eligibility Overview:

  • Participant is < 19 years of age at the time of study enrollment.
  • Participant has newly diagnosed, advanced stage, high-risk neuroblastoma.
  • Participant has histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamine.
  • Participant has adequate renal and hepatic function.

Description

Treatment for children with high-risk neuroblastoma is usually done in three phases:

  • Induction therapy (first line treatment with chemotherapy and surgery to kill and then remove as much tumor as possible)
  • Consolidation therapy (Radiation therapy and high-dose chemotherapy with stem cell infusion or auto-transplant that is given after induction to kill any remaining cancer cells)
  • Minimal Residual Disease (MRD) therapy (designed to kill small number of cancer cells that may be left.

Objectives

The main goal of this research study is to find out if adding an investigational monoclonal antibody called hu14.18K322A to the first two cycles of induction chemotherapy will result in better tumor responses, compared to treatment given to children in past studies that did not include the antibody.

In addition, we also want to find out if giving this antibody with further cycles of induction, consolidation and MRD therapy will be beneficial. Finally, we want to find out if giving a type of white blood cell from a parent donor, called Natural Killer (NK) cells, starting two days after stem cell infusion, during consolidation therapy, will benefit children with high risk neuroblastoma.

Other Objectives

  • To learn more about the effects (good and bad) of hu14.18K322A mAb when given with chemotherapy, immediately after stem cell transplant and during the MRD phase of treatment.
  • To learn more about the effects (good and bad) of giving a type of radiation therapy called “intensity modulated radiation therapy” to participants with neuroblastoma in the abdomen (belly).
  • To find out if hu14.18K322A mAb combined with an infusion of NK cells from a parental donor can be given safely immediately after stem cell transplant/rescue.
  • To find out what dose of hu14.18K322A mAb is tolerated when given with IL-2, GM-CSF and Accutane, during MRD phase of treatment.

Eligibility criteria, among other, include (Participant)

  • Participant is < 19 years of age at the time of study enrollment.
  • Participant has newly diagnosed, advanced stage, high-risk neuroblastoma.
  • Participant has histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamine.
  • Participant has adequate renal function.
  • Participant has adequate hepatic function. 

Contact

Wayne L. Furman, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.