OncoMatch/Clinical Trials/NCT07027748
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Is NCT07027748 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Naxitamab and Irinotecan for neuroblastoma.
Treatment: Naxitamab · Irinotecan · Temozolomide · Sargramostim granulocyte-macrophage colony stimulating factor — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Must have received: high-risk neuroblastoma therapy — frontline
Any prior episode of recurrent high-risk disease following completion of frontline high-risk therapy; Prior progressive high-risk disease during frontline high-risk therapy; Primary resistant/refractory disease detected after at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol
Cannot have received: naxitamab (naxitamab)
Prior receipt of naxitamab
Cannot have received: irinotecan (irinotecan)
Exception: discontinuation due to unacceptable toxicity or prior allergic reaction
Prior allergic reaction to irinotecan; Discontinuation of prior irinotecan due to unacceptable toxicity
Cannot have received: temozolomide (temozolomide)
Exception: discontinuation due to unacceptable toxicity or prior allergic reaction
Prior allergic reaction to temozolomide; Discontinuation of prior temozolomide due to unacceptable toxicity
Cannot have received: GD2 directed immunotherapy
Exception: discontinuation due to unacceptable toxicity other than allergic reaction
Discontinuation of prior GD2 directed immunotherapy due to unacceptable toxicity other than allergic reaction
Cannot have received: allogeneic stem cell transplant
Patients are not eligible post allogeneic stem cell transplant
Lab requirements
Blood counts
Peripheral ANC ≥ 750/uL (with myeloid growth factor washout); Peripheral platelet count ≥ 75,000/uL (without support, ≥7 days from last transfusion/platelet stimulating agent)
Kidney function
Radioisotope GFR ≥ 70ml/min/1.73 m2 OR serum creatinine based on age/sex (see table)
Liver function
Total bilirubin ≤ 1.5 x ULN for age; ALT ≤ 3.0 x ULN for age (≤ 135 U/L, ULN for ALT is 45 U/L); Albumin > 3 g/dL; If Gilbert syndrome, direct bilirubin must be within normal limits for age
Cardiac function
Shortening fraction of ≥ 27% OR ejection fraction of ≥ 50%; No clinically significant arrhythmias
Adequate bone marrow function as defined as BOTH of the following: Peripheral absolute neutrophil count (ANC) ≥ 750/uL...Peripheral platelet count ≥ 75,000/uL...Adequate renal function as defined as EITHER of the following: Radioisotope GFR ≥ 70ml/min/1.73 m2 OR serum creatinine based on age/sex...Adequate liver function defined as ALL of the following: Total bilirubin ≤ 1.5 x ULN for age; ALT ≤ 3.0 x ULN for age (≤ 135 U/L, ULN for ALT is 45 U/L); Albumin > 3 g/dL; If Gilbert syndrome, direct bilirubin must be within normal limits for age...Adequate cardiac function measured by echocardiogram as defined as EITHER of the following: Shortening fraction of ≥ 27% OR ejection fraction of ≥ 50%; No clinically significant arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Boston Children's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
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