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:

  • Younger than 19 years old
  • Newly diagnosed, advanced stage, high-risk neuroblastoma
  • Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamine
  • Adequate kidney and liver functions
  1. Brief Summary

    Neuroblastoma is the most common extracranial solid tumor in childhood. Treatment is usually given in three phases:

    • Induction therapy
    • Consolidation therapy
    • Minimal Residual Disease (MRD) therapy

    This study is a pilot Phase II study of a unique anti-disialoganglioside (anti-GD2) monoclonal antibody (mAb) called hu14.18K322A, given with induction chemotherapy. Recent studies suggest the combination of chemotherapy with monoclonal antibodies can be synergistic.

    Primary Objectives include

    • To study the effects of two initial courses of cyclophosphamide and topotecan combined with hu14.18K322A in previously untreated children with high-risk neuroblastoma
    • To estimate event-free survival of patients with the addition of hu14.18K322A to each phase of treatment

    Secondary Objectives include

    • To study the feasibility of delivering hu14.18K322A to 6 cycles induction chemotherapy and describe antitumor activity
    • To study the effects of focal intensity modulated or proton beam therapy dose delivery in high-risk abdominal neuroblastoma

    Eligibility Criteria:

    Inclusion criteria include:

    • Younger than 19 years old
    • Newly diagnosed, advanced stage, high-risk neuroblastoma
    • Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamine
    • Adequate kidney and liver  functions

    Exclusion criteria include:

    • Evidence of severe or uncontrolled systemic disease
    • Pregnant or breast-feeding
    • INSS 4 disease, younger than 18 months old with all 3 favorable biologic features

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

    Collaborating institutions in the U.S.

  2. About this study

    Neuroblastoma is a cancer of the nerve cells. Neuroblastoma that spreads to other parts of the body or is hard to treat is called high-risk neuroblastoma.

    Current treatment for high-risk neuroblastoma includes strong anti-cancer drugs (chemotherapy), surgery, radiation therapy and stem cell transplant. In this study, doctors will add an experimental drug to the chemotherapy. The experimental drug is called a monoclonal antibody.

    Antibodies are part of the body’s normal immune (defense) system. They help look for and attack cells that seem “different” and harmful. These can include bacteria, viruses and cancer cells. Monoclonal antibodies are proteins made in laboratories. They are designed to find and attach themselves to cancer cells. This process activates the body’s immune system to attack and kill the cancer cells without destroying nearby healthy cells.

    Purpose of this clinical trial

    The main goal of this study is to find out if adding this experimental antibody to standard treatment will result in better tumor responses, compared to treatment given to children in past studies.

    Eligibility overview

    • Younger than 19 years old
    • Newly diagnosed, advanced stage, high-risk neuroblastoma
    • Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamine
    • Adequate kidney and liver functions
  3. NB2012 Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT01857934
    Trial Start Date July 2013
    Estimated Enrollment 65
    Study Type Interventional
    Study Phase Phase II
    Conditions Neuroblastoma
    Ages Younger than 19 years 
    Principal investigator Wayne L. Furman, MD
    Study Sites St. Jude Children’s Research Hospital 
    For a consultation or to discuss NB2012 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

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
Email: 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.