A Phase II Study With a Safety Run-In of the Addition of N-803, a Novel IL-15 Super-Agonist, to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma
St. Jude Children's Research Hospital
Summary
The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed). Primary Aims * To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed/refractory neuroblastoma is feasible and tolerable * To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF Secondary Aims * To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF * To evaluate and compare the progression free survival (PFS) and overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803
Description
This is a randomized phase 2 study with a safety assessment run-in conducted in children with relapsed or refractory neuroblastoma to evaluate the feasibility, tolerability, and response to chemoimmunotherapy backbone (irinotecan, temozolomide, hu14.18K322A and GM-CSF) with or without N-803. The first 6 patients included in the safety assessment run-in phase will receive irinotecan, temozolomide, hu14.18K322A, GM-CSF and N-803. If fewer than 2 patients in the first cohort of 6 patients experience a DLT in Cycle 1, then the trial will proceed Phase 2. If 2 or more of the first 6 patients experi…
Eligibility
- Age range
- Up to 30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Age \- Patients must be \< 30 at the time of enrollment on study. Diagnosis \- Patients must have had histologic verification of neuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary or serum catecholamines \[i.e., \> 2 x upper limit of normal (ULN)\], at the time of initial diagnosis. Disease Risk Group * Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but were then reclassified as high-ri…
Interventions
- DrugTemozolomide
IV, Days 1-5
- DrugIrinotecan
IV, Days 1-5
- Drughu14.18K322A
IV over 4 hours daily times 4 doses, Days 2-5.
- DrugN803
Subcutaneous (SC), Day 6.
- DrugSargramostim
Subcutaneous injection (preferred) or IV, Days 7-13.
Location
- St. Jude Children's Research HospitalMemphis, Tennessee