Actively Recruiting
A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma
Led by St. Jude Children's Research Hospital · Updated on 2026-02-17
54
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be younger than 30 years old at enrollment.
- Must have histologic confirmation of neuroblastoma or neuroblastoma cells in bone marrow with elevated catecholamines at initial diagnosis.
- Must have high-risk neuroblastoma at study registration.
- Must have recurrent, progressive, refractory, or persistent disease following initial high-risk neuroblastoma diagnosis.
- Must have at least one measurable bone, bone marrow, or soft tissue lesion as defined by imaging and biopsy criteria.
- Must have Lansky or Karnofsky performance score of 50 or higher.
- Must have recovered from prior chemotherapy, immunotherapy, or radiotherapy and meet specified timing intervals since last treatment.
- Must not be receiving prohibited concomitant therapies including certain steroids and strong CYP3A4 inducers or inhibitors.
- Must meet specified hematologic, renal, liver, cardiac, and pulmonary function criteria.
- Post-menarchal females must have a negative pregnancy test and agree to use effective contraception; patients of reproductive potential must agree to use two contraception methods or abstain from heterosexual intercourse during the study.
You will not qualify if you...
- Pregnancy or breastfeeding or unwillingness to use effective contraception.
- Inability to comply with safety monitoring requirements.
- Disease affecting major organs compromising ability to tolerate therapy.
- Prior allogeneic stem cell or solid organ transplant.
- Patients on hemodialysis.
- Active or uncontrolled infection.
- Known HIV, hepatitis B, or hepatitis C infection.
- Requirement for pharmacologic doses of systemic corticosteroids (except limited exceptions).
- Use of immunosuppressive medications such as cyclosporine or tacrolimus.
- Use of enzyme-inducing anticonvulsants within 7 days prior to enrollment.
- Use of strong CYP3A4 inducers or inhibitors within 7 days prior to enrollment.
- Diagnosis of myelodysplastic syndrome or malignancies other than neuroblastoma.
- Symptoms of congestive heart failure.
- Greater than Grade 2 diarrhea.
- History of progressive disease on certain prior anti-GD2 therapy regimens.
- History of severe allergic reactions to anti-GD2 antibodies.
- Elevated catecholamines without evidence of disease.
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Sara Federico, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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