Rapid Infusion Study for Dinutuximab in Children with High-Risk Neuroblastoma

Sponsor: Children's Hospital Los Angeles

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05421897

Provider View

This study is testing if the cancer treatment drug dinutuximab can be given more quickly to children with high-risk neuroblastoma, potentially allowing for outpatient treatment and reducing hospital stays.

Patient Parameters

Program Overview

This study aims to find out if the cancer treatment drug dinutuximab can be safely given to children with high-risk neuroblastoma in a shorter time, possibly allowing it to be administered outside of the hospital. Dinutuximab is usually given over 10-20 hours, but this study will test if it can be given in 4 hours or less. This could make treatment easier for patients and reduce hospital stays and costs. The study will look at how the drug is processed in the body, its side effects, and the care needed during treatment to see if this faster method is safe and effective.

Description

Neuroblastoma is a common childhood cancer that can be very serious, especially in high-risk cases. Dinutuximab is a drug that has improved survival rates for children with this type of cancer. However, it usually requires long hospital stays because it takes a long time to administer and can cause side effects like pain and low blood pressure. This study is exploring whether dinutuximab can be given more quickly, which could allow it to be administered in outpatient settings, reducing the need for hospital stays.

The study will test if dinutuximab can be given in 4 hours or less, instead of the usual 10-20 hours. This could make treatment more convenient and less costly. The study will monitor how the drug is absorbed and its side effects to ensure the faster method is safe. If successful, this could change how dinutuximab is given to children with high-risk neuroblastoma, making it easier for families and healthcare providers.

Eligibility Criteria

Inclusion Criteria

  • Children aged 12 months and older.
  • Diagnosed with high-risk neuroblastoma or ganglioneuroblastoma that has returned, not responded well to treatment, or is persistent.
  • Must have completed at least 4 cycles of high-risk chemotherapy.
  • At least 14 days since last chemotherapy.
  • Must have received dinutuximab before.
  • Must be off certain medications and treatments for specified times before starting the study.
  • Must have adequate bone marrow, kidney, liver, heart, and lung function.
  • Must not have active central nervous system disease.
  • Must not require high doses of steroids.
  • Must not have had a stem cell transplant within 42 days before starting the study.

Exclusion Criteria

  • Must agree to use effective birth control if of childbearing potential.
  • Cannot be pregnant or breastfeeding.
  • Cannot have received certain medications or treatments recently.
  • Cannot have other types of cancer or uncontrolled infections.
  • Cannot have had severe allergic reactions to similar treatments.
  • Cannot have significant health issues that would make the study treatment unsafe.

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