Trial Search Results

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

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Other: Clinical Observation
  • Drug: Carboplatin
  • Drug: Etoposide
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must be:

      - < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or

      - < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms
      neuroblastoma/ganglioneuroblastoma

   - Enrollment on ANBL00B1 is required for all newly diagnosed patients

   - Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene
   neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International
   Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN
   non-amplified ganglioneuroblastoma verified by histology

   - Patients must meet the specified criteria for one of the treatment groups defined
   below; genomic features include MYCN gene amplification, segmental chromosome
   aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number
   gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index

      - "Favorable" genomic features are defined by one or more whole-chromosome gains or
      hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome
      aberrations as defined above

      - "Unfavorable" genomic features are defined by the presence of any segmental
      chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic
      copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this
      includes copy neutral loss of heterozygosity (LOH)

      - Only patients with MYCN non-amplified tumors are eligible for this study

   - Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1
   neuroblastoma/ganglioneuroblastoma who meet the following criteria:

      - Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin

      - Patients with non-adrenal primaries are eligible, but must have positive uptake
      on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites
      (urine or serum) to support the diagnosis of neuroblastoma

      - No prior tumor resection or biopsy

   - Group A will be further split into two subsets, which are mutually exclusive, for
   statistical purposes

      - Group A1:

         - > 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in
         greatest diameter OR

         - Patients less than 6 months of age with an adrenal primary tumor > 3.1 and <
         5 cm in greatest diameter OR

         - < 12 months of age with a non-adrenal primary site < 5 cm in greatest
         diameter

      - Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in
      greatest diameter.

   - Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2
   neuroblastoma/ganglioneuroblastoma who meet the following criteria:

      - No life threatening symptoms or no impending neurologic or other organ function
      compromise (e.g. epidural or intraspinal tumors with existing or impending
      neurologic impairment, periorbital or calvarial-based lesions with existing or
      impending cranial nerve impairment, anatomic or mechanical compromise of critical
      organ function by tumor [abdominal compartment syndrome, urinary obstruction,
      etc.])

      - No prior tumor resection, tumor biopsy ONLY

      - Only patients with both favorable histology and favorable genomic features will
      remain on study as part of Group B; the institution will be notified of
      histologic and genomic results within 3 weeks of specimen submission on ANBL00B1

   - Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms
   neuroblastoma/ganglioneuroblastoma

   - No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is
   allowed

   - All patients and/or their parents or legal guardians must sign a written informed
   consent

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patients with MYCN amplified tumors are not eligible

   - Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive
   diagnostic procedure

   - Group A and C patients, not required to undergo tumor biopsy, who do not enroll on
   ANBL1232 within 4 weeks of confirmatory imaging study

Ages Eligible for Study

N/A - 17 Months

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christina Baggott
650-497-7659
Recruiting