This phase II trial studies the side effects of naxitamab, irinotecan hydrochloride, temozolomide, and sargramostim in treating patients with high-risk neuroblastoma. Immunotherapy with naxitamab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as irinotecan hydrochloride, temozolomide, and sargramostim, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving naxitamab, irinotecan hydrochloride, temozolomide, and sargramostim may work better in treating patients with high-risk neuroblastoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03189706.
PRIMARY OBJECTIVE:
I. To evaluate the safety of the combination of irinotecan hydrochloride (irinotecan), temozolomide, naxitamab (hu3F8) and sargramostim (granulocyte-macrophage colony-stimulating factor [GM-CSF]) (HITS) in patients with neuroblastoma (NB).
SECONDARY OBJECTIVES:
I. To evaluate tumor responses to HITS in patients with NB.
II. To evaluate pharmacokinetics of hu3F8.
III. To evaluate natural killer (NK) cell activation in patients treated with HITS.
IV. To evaluate serum cytokines in patients receiving HITS.
EXPLORATORY OBJECTIVE:
I. To evaluate minimal residual disease (MRD) changes in in bone marrow (BM).
OUTLINE:
Patients receive irinotecan hydrochloride intravenously (IV) over 60 minutes on days 1-5, temozolomide orally (PO) or IV on days 1-5, naxitamab IV over 30-90 minutes on days 2, 4, 8, and 10, and sargramostim subcutaneously (SC) on days 6-10. Cycles repeat every 21-42 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 42 days.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorShakeel Modak
