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
52 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
Researchers are studying a treatment plan combining Naxitamab, Irinotecan, Temozolomide, and Sargramostim to see if giving Naxitamab more slowly can reduce side effects like pain in patients aged 1 to 30 years with relapsed or refractory neuroblastoma. This phase 1 trial aims to find the safest infusion duration of Naxitamab while monitoring how patients tolerate different speeds of administration. Participants will receive Naxitamab through intravenous infusions at varying durations (3, 4, or 5 hours) along with Irinotecan and Temozolomide chemotherapy and Sargramostim injections following a set schedule over six 21-day cycles. The study begins with a baseline visit, followed by cycles where Naxitamab is given on days 1, 3, and 5; Temozolomide and Irinotecan are given on days 1 through 5; and Sargramostim is administered from days 6 to 12. Imaging tests occur during specific cycles, and participants will have an end-of-treatment visit plus a one-year follow-up. During the study, participants undergo various assessments including blood work, CT, MRI, or MIBG scans, echocardiograms, and bone marrow biopsies. Researchers closely monitor pain and other infusion-related side effects using several pain measurement scales throughout treatment cycles. The main outcome is to determine the recommended Naxitamab infusion duration by the end of the first treatment cycle, with additional measures including response to treatment, survival rates, and safety tracked during and after therapy.
CONDITIONS
Brief 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 verification of neuroblastoma or ganglioneuroblastoma or evidence of neuroblastoma cells in bone marrow with elevated urinary catecholamines at initial diagnosis
- Relapsed or refractory high-risk neuroblastoma as defined by prior disease status
- Measurable tumor on MRI or CT scan or MIBG-avid or FDG-avid lesions on scans representing recurrence or refractory disease
- Prior therapies allowed with specific washout periods before enrollment
- Age between 1 and 30 years at enrollment
- Adequate performance status (Karnofsky ≥70% if age ≥16, Lansky ≥70% if younger)
- Adequate bone marrow, renal, liver, cardiac, blood pressure, pulmonary, and pancreatic function as specified
- Ability to comply with protocol requirements
- Use of adequate contraception for those able to become pregnant or impregnate a partner
- Informed consent provided by participant or legally authorized representative
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 individuals
- Clinically significant arrhythmias causing symptoms or needing medication
- Prior allergic reaction or discontinuation of irinotecan or temozolomide due to toxicity
- Discontinuation of prior GD2-directed immunotherapy due to unacceptable toxicity other than allergy
- Serious ongoing illness or active uncontrolled infection
- Major organ dysfunction greater than grade 2 except specified exceptions
- Use of immunosuppressive medications or concurrent anti-cancer agents or radiotherapy
- Recent use of valproic acid, strong CYP3A4 or UGT1A1 inhibitors or inducers within 14 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 6 cycles of 21 days each (approximately 18 weeks)
Participants receive cycles of Naxitamab, Irinotecan, Temozolomide, and Sargramostim to treat relapsed or refractory neuroblastoma. Treatment cycles last 21 days each, with specific dosing schedules for each medication during the cycles.
Visits on Days 1, 3, 5 for Naxitamab infusions and Days 1 through 12 for medication administration and assessments per cycle
Duration - 1 year post-treatment
Participants are monitored for safety and disease status, including survival and progression-free survival assessments, for one year after treatment ends.
Quarterly visits for follow-up assessments
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
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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