Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma

Sponsor
Princess Maxima Center for Pediatric Oncology
Study ID
NCT06485947
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dinutuximab beta — BIOLOGICAL
    Combination of immunotherapy with standard chemotherapy
  • chemotherapy treatment called GPOH — DRUG
    chemotherapy treatment called GPOH
  • chemotherapy treatment called rapid COJEC — DRUG
    chemotherapy treatment called rapid COJEC

Study Details

The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is: • to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens Participants will receive: * GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals. * Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.

Key Dates

First listed
Jul 3, 2024
Start date
Jan 28, 2025
Status verified
Jul 2025
Primary completion
Jul 1, 2030
Completion
Dec 1, 2031

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dinutuximab Beta with chemotherapy treatment called GPOH
    Dinutuximab Beta will be administered at a fixed daily dose of 10 mg/m2 given as a 24-hour continuous infusion for a scheduled number of days within each treatment cycle of chemotherapy.
  • Experimental: Dinutuximab Beta with chemotherapy treatment called rapid COJEC
    Dinutuximab Beta will be administered at a fixed daily dose of 10 mg/m2 given as a 24-hour continuous infusion for a scheduled number of days within each treatment cycle of chemotherapy.

Primary Outcome Measure

the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with GPOH chemotherapy regimen [ Time Frame: Within first 63 days of treatment ]

Central Contacts

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