This phase II trial tests how well 3 different combinations of chemotherapy drugs that are given at different times (N10 chemotherapy) works in treating children with high-risk neuroblastoma before they receive additional treatments. N10 chemotherapy drugs, cyclophosphamide, topotecan, vincristine, ifosfamide, carboplatin, etoposide and doxorubicin, 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 N10 chemotherapy may kill more tumor cells and may make it less likely that cancer will stop responding (become resistant) to the chemotherapy treatment. N10 chemotherapy may have fewer side effects than the usual treatment approach. Giving N10 chemotherapy may be safe and effective in treating children with high-risk neuroblastoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06528496.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
PRIMARY OBJECTIVE:
I. To assess the early complete response (CR) rate in newly-diagnosed high-risk neuroblastoma (HR-NB) patients.
SECONDARY OBJECTIVES:
I. To assess severe toxicities rate.
II. To estimate the progression-free survival and overall survival rate of newly-diagnosed HR-NB patients treated with the N10 strategy.
OUTLINE:
INDUCTION:
INDUCTION CYCLES 1 AND 4: Patients receive cyclophosphamide intravenously (IV) over 6 hours on days 1 and 2, topotecan IV over 30 minutes on days 1 to 4 and vincristine IV over 10 minutes on day 1.
INDUCTION CYCLE 2: Patients receive ifosfamide IV over 6 hours on days 1 to 5, carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1 to 5.
INDUCTION CYCLE 3: Patients receive cyclophosphamide IV over 6 hours on days 1 and 2, doxorubicin IV over 24 hours on days 1 to 3 and vincristine IV over 24 hours on days 1 to 3. Patients also undergo peripheral blood stem cell collection and surgery per usual care following cycle 3.
Cycles repeat every 21 to 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
POST INDUCTION: Patients with CR, minor response (MR), or stable disease (SD) post-induction therapy receive naxitamab IV over 30 to 240 minutes on days 1, 3 and 5 and granulocyte-macrophage colony-stimulating factor (GM-CSF) subcutaneously (SC) on days -2 to 0 and on days 1 to 7. Patients with partial remission (PR) or with residual neuroblastoma (NB) post-induction therapy receive irinotecan IV over 1 hour on days 1 to 5, temozolomide IV over 1.5 hours on days 1 to 5, naxitamab IV over 30 to 240 minutes on days 2, 4, 9 and 11 and GM-CSF SC on day 6 to 13 as clinically indicated. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy per usual care between cycle 1 and 2.
Additionally, patients undergo bone marrow (BM) aspiration and biopsy, computed tomography (CT) scan, magnetic resonance imaging (MRI), I-meta-iodobenzylguanidine (MIBG) scan, positron emission tomography (PET) scan, and echocardiography (ECHO) on study and as clinically indicated.
After completion of treatment, patients are followed up at 45 days and then every 6 months for up to 5 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorBrian Harris Kushner
