NBL1232: Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-High Risk Neuroblastoma

Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma (ANBL1232)

Category:

Solid Tumor

Diseases Treated:

Neuroblastoma, ganglioneuroblastoma

Eligibility Overview:

  • Participant has been enrolled on ANBLB1 (ANBL00B1).
  • Participant has newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
  • Participant is less than 12 months (Group A) and less than 18 months (Group B and Group C) of age at diagnosis.

 

Description

Neuroblastoma (NBL) is a type of cancer that occurs in nerve cells outside of the brain. Treatment for NBL is determined by certain risks factors including: The tumor stage, which is based on whether the tumor has stayed in one place or if it has spread to other parts of the body, the child’s age at diagnosis, and the biologic features of the tumor. Currently the standard therapy for non-high risk NBL or ganglioneuroblastoma includes surgery alone to remove the tumor or chemotherapy to make the tumor smaller followed by surgery. Although this approach results in excellent cure rates there is evidence that some of these patients may not need surgery or chemotherapy. This study will be enrolling participants less than one year of age who have a small mass (tumor) that is not involving other vital structures and is believed to be a non-high-risk neuroblastoma (NBL) or ganglioneuroblastoma or patients up to 18 months of age with tumors whose tumors have limited involvement of other vital structures or have spread to skin, liver or bone marrow (small amount).. In this study participants will be enrolled in 1 of 3 groups; Group A, Group B, or Group C. Group assignment is based on the aforementioned risk factors. The overall goal for all participants in all groups in this study is to see if the doctors can treat non-high-risk NBL by either not doing surgery or by reducing the amount of chemotherapy given and still get very good results.

Objectives

  • To eliminate therapy as the initial approach for infants less than twelve (12) months of age with small INRG Stage L1 neuroblastoma while maintaining an overall survival (OS) of ninety-nine (99) percent.
  • To eliminate therapy as the initial approach for non-high-risk patients less than eight-teen (18) months of age with localized neuroblastoma and favorable biology (histologic and genomic features) while maintaining an OS of ninety-nine (99) percent.
  • To achieve a three (3) year overall survival of greater than eighty-one (81) percent for infants less than eight-teen (18) months of age with INRG Stage Ms neuroblastoma using objective criteria for early initiation of a response-based treatment algorithm.

Eligibility Criteria

Inclusion Criteria Group A:

  • Participant has been enrolled on ANBLB1 (ANBL00B1).
  • Participant has newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
  • Participant diagnosis has been verified by histology.
  • Participant is less than twelve (12) months (less than 365 days) of age at diagnosis.
  • Participant has newly diagnosed INRG Stage L1 neuroblastoma whose tumor is < 5 cm in greatest diameter.
  • Participant has no prior tumor resection or biopsy.

Inclusion Criteria Group B:

  • Participant has been enrolled on ANBLB1 (ANBL00B1).
  • Participant has newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
  • Participant diagnosis has been verified by histology.
  • Participant less than eight-teen (18) months (less than 547 days) of age at diagnosis.
  • Participant with newly diagnosed INRG Stage L2 neuroblastoma (no life threatening symptoms or impending neurologic or other organ function compromise.

Inclusion Criteria Group C:

  • Participant has been enrolled on ANBLB1 (ANBL00B1).
  • Participant has newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
  • Participant diagnosis has been verified by histology
  • Participant is less than eight-teen (18) months (547 days) of age and has newly diagnosed INRG Stage Ms neuroblastoma.
  • Participant has received no prior radiotherapy or chemotherapy, with the exception of dexamethasone.

Exclusion Criteria:

  • Participant has MYCN amplified tumor.
  • Group B or C participant who does not enroll on this study within four (4) weeks of definitive diagnostic procedure
  • Group A or C participant not required to undergo tumor biopsy, who does not enroll on this study within four (4) weeks of confirmatory imaging study.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Wayne 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
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.