ANBL19P1: A Pilot Study of Dinutuximab Sargramostim (GM-CSF) and Isotretinoin in Combination with Irinotecan and Temozolomide in the Post-Consolidation Setting for High-Risk Neuroblastoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    High-risk Neuroblastoma
  • Age: Between 0 - 30 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. 1. Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) (verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites at the time of diagnosis) and have been designated as having high-risk disease based on Children's Oncology Group (COG) risk classification.
    2. 2. All patients must have completed high-risk Induction therapy with 4-6 cycles of chemotherapy.
    3. 3. Adequate bone marrow function and adequate renal function.

You may not be eligible for this study if the following are true:

    1. 1. Patients must not have had progressive disease (PD) per the revised International Neuroblastoma Risk Criteria (INRC)28 since the initial diagnosis of high-risk neuroblastoma.
    2. 2. Patients may not have received additional systemic cancer-directed therapy following completion of the last planned high-dose chemotherapy with ASCT prior to enrollment on this trial.
    3. 3. Patients may not have received 131I-MIBG therapy at any time prior to enrollment on this trial.
    4. 4. Patients who received single (rather than tandem) high-dose chemotherapy with ASCT are excluded.



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