Actively Recruiting
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Led by Steven DuBois, MD · Updated on 2025-07-14
18
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
Sponsors
S
Steven DuBois, MD
Lead Sponsor
Y
Y-mAbs Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma. The name of the study drugs involved in this study are: * Naxitamab (A type of monoclonal antibody) * Irinotecan (A standard of care chemotherapy) * Temozolomide (A standard of care chemotherapy) * Sargramostim (A standard of care, granulocyte-macrophage colony stimulating factor)
CONDITIONS
Official Title
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic confirmation of neuroblastoma or ganglioneuroblastoma or evidence of neuroblastoma cells in bone marrow with elevated urinary catecholamines at initial diagnosis
- Relapsed, progressive, or refractory high-risk neuroblastoma after prior therapies
- At least one measurable tumor lesion on MRI or CT (≥10 mm), or MIBG-avid lesion, or FDG-avid lesion on PET for disease recurrence or refractory disease
- No isolated bone marrow only disease
- Prior anticancer therapy with specified washout periods (e.g., 14 days for chemotherapy, 7 days for monoclonal antibodies)
- Age between 1 and 30 years at enrollment
- Performance status Karnofsky ≥70% (≥16 years) or Lansky ≥70% (<16 years)
- Adequate bone marrow function (ANC ≥750/uL and platelet count ≥75,000/uL without recent support)
- Adequate renal function by GFR or age/sex creatinine limits
- Adequate liver function with specified bilirubin, ALT, and albumin limits
- Adequate cardiac function with shortening fraction ≥27% or ejection fraction ≥50%
- Controlled blood pressure (< Grade 2 hypertension, on no more than one antihypertensive)
- Adequate pulmonary function (no dyspnea at rest, no exercise intolerance, O2 saturation >94%, no chronic oxygen therapy)
- Adequate pancreatic function (lipase <1.5 x upper limit of normal)
- Willingness and ability to use adequate contraception during and 4 months after study
- Ability to understand and provide informed consent (or parent/legal guardian consent)
You will not qualify if you...
- Chronic diarrhea lasting more than 2 weeks and greater than grade 1
- Prior treatment with naxitamab
- Untreated central nervous system metastatic disease
- Pregnant or breastfeeding participants
- Clinically significant arrhythmias causing symptoms or requiring medication
- Prior allergic reaction to irinotecan or temozolomide
- Discontinuation of prior irinotecan or temozolomide due to unacceptable toxicity
- Discontinuation of prior GD2 immunotherapy due to unacceptable toxicity except allergy
- Serious concurrent illness or active uncontrolled infection
- Major organ dysfunction greater than CTCAE Grade 2 except certain hearing, hematologic, kidney, and liver functions
- Use of immunosuppressive medications excluding local or inhaled steroids
- Concurrent anti-cancer treatments or radiotherapy
- Recent valproic acid use within 14 days
- Recent use of strong CYP3A4 or UGT1A1 inhibitors or inducers within 14 days
- Post allogeneic stem cell transplant
- Patients receiving cellular therapies within 21 days or not recovered from toxicities
- Inability to comply with study requirements or contraception guidance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Steven DuBois, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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