Study on Adding Naxitamab to Initial Treatment for Newly Diagnosed High-Risk Neuroblastoma

Sponsor: Giselle Sholler

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05489887

Provider View

This clinical trial is testing whether adding the drug naxitamab to the standard initial treatment can improve outcomes for children with newly diagnosed high-risk neuroblastoma. The study will evaluate the safety and effectiveness of this combination therapy.

Patient Parameters

Program Overview

This study is exploring whether adding naxitamab to the standard initial treatment for high-risk neuroblastoma can improve treatment responses and survival rates. Participants will receive five cycles of chemotherapy with naxitamab added to each cycle. The study will monitor disease response, survival rates, and any side effects. Participants will also undergo stem cell collection and possibly surgery to remove the primary tumor. The study aims to improve the current treatment outcomes for high-risk neuroblastoma, which currently has a survival rate of less than 60%.

Description

This clinical trial is designed to test the safety and effectiveness of adding naxitamab to the standard initial treatment for children with newly diagnosed high-risk neuroblastoma. The study will involve multiple centers and will follow participants to monitor their response to treatment, survival rates, and any side effects.

Participants will receive five cycles of chemotherapy, with naxitamab added to each cycle. After the second cycle, stem cells will be collected for potential future use. Surgery to remove the primary tumor is planned after the fourth cycle but may be delayed if necessary. The study will evaluate the disease status at several points, including before treatment, after the second cycle, before surgery, at the end of the induction phase, and after any additional therapy.

The current standard treatment for high-risk neuroblastoma includes several cycles of chemotherapy, surgery, high-dose chemotherapy with stem cell transplant, radiation, and additional therapies. This study aims to improve the initial response to treatment and overall survival by adding naxitamab to the initial chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Must have a diagnosis of neuroblastoma or ganglioneuroblastoma confirmed by specific tests.
  • Must be newly diagnosed with high-risk neuroblastoma at certain stages and meet specific criteria based on age and biological features.
  • Must be 21 years old or younger at initial diagnosis.
  • Must be over 12 months old at enrollment.
  • Must be able to undergo stem cell collection without known contraindications.
  • Must have adequate heart function as shown by specific tests.
  • Must have adequate liver function based on specific blood test results.
  • Must have adequate kidney function based on age and gender-specific serum creatinine levels.
  • Female participants of childbearing potential must have a negative pregnancy test.
  • Post-pubertal participants must agree to use effective contraception during and after the study.
  • Must provide informed consent signed by the participant or legal guardian.

Exclusion Criteria

  • Under 1 year of age.
  • 12-18 months old with certain stages of neuroblastoma and favorable biological features.
  • Have had prior systemic therapy, except for specific emergency treatments.
  • Have received immunosuppressive treatment within 4 weeks before enrollment.
  • Have inadequate lung function or require oxygen.
  • Pregnant or breastfeeding.
  • Receiving any other investigational drug at the same time.
  • Have other medical conditions that could interfere with the study or its results.
  • Have a significant ongoing medical problem unrelated to cancer that could affect the study.

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