Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Steven DuBois, MD
Study ID
NCT07027748
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Naxitamab — DRUG
    Recombinant humanized anti-GD2 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.
  • Irinotecan — DRUG
    Topoisomerase Inhibitor, single-dose vial, via intravenous infusion per standard of care
  • Temozolomide — DRUG
    Alkylating agent, capsule, via orally (by mouth) per standard of care
  • Sargramostim granulocyte-macrophage colony stimulating factor — DRUG
    Recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF), multi-use vial, via subcutaneously (under the skin) injection per standard of care

Study Details

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)

Key Dates

Start date
Jun 27, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Naxitamab Infusion+ Ironotecan + Temozolomide + Sargramostim
    Participants will be enrolled in a modified 3+3 design to establish a maximum tolerated, infusion duration for Naxitamab. Dosage will start at Duration Level 1 and will de-escalate to Duration Level -1 or escalate to Duration Level 2 according to dose-limiting toxicity (DLT) criteria. * Baseline visit * Cycle 1 (21 day cycle): * Days 1, 3, and 5: Predetermined dose of Naxitamab 1x daily * Days 1 through 5: Predetermined dose of Temozolomide 1x daily * Days 1 through 5: Predetermined dose of Ironotecan 1x daily * Days 6 through 12: predetermined dose of Sargramostim 1x daily * Cycles 2 through 6 (21 day cycles): * Imaging on Cycles 2, 4, and 6 * Days 1, 3, and 5: Predetermined dose of Naxitamab 1x daily * Days 1 through 5: Predetermined dose of Temozolomide 1x daily * Days 1 through 5: Predetermined dose of Ironotecan 1x daily * Days 6 through 12: predetermined dose of Sargramostim 1x daily * End of treatment visit * Follow up at 1 year post-treatment

Primary Outcome Measure

Recommended duration of naxitamab infusion [ Time Frame: Assessed at the end of the first cycle of treatment, where 1 cycle is 21 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Steven DuBois, MD, MS
[email protected]
617-632-5460
Steven DuBois, MD, MS (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Steven DuBois, MD, MS
[email protected]
617-632-5460
Steven DuBois, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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