Study on MIBG Treatment with Vorinostat and Dinutuximab for Neuroblastoma

Sponsor: New Approaches to Neuroblastoma Therapy Consortium

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07261241

Provider View

This clinical trial is testing different combinations of MIBG treatment with the drugs Vorinostat and Dinutuximab to find the best approach for treating neuroblastoma in children and young adults.

Patient Parameters

Program Overview

In this study, patients with neuroblastoma will be randomly assigned to one of three treatment groups. Each group will receive a different combination of MIBG treatment with the drugs Vorinostat and Dinutuximab. After the treatment, doctors will check how well the cancer responds and monitor the patients' health over time. If patients and their doctors agree, they may choose to have a second round of the same treatment. The study aims to find the most effective treatment combination for future research.

Description

This study is designed to find the best combination of MIBG treatment with Vorinostat and Dinutuximab for treating neuroblastoma. There are three groups in the study: one group will receive MIBG with Vorinostat, another will receive MIBG with Dinutuximab, and the third will receive MIBG with both Vorinostat and Dinutuximab. The main goal is to see which combination works best in shrinking the cancer after one round of treatment. About 118 patients will participate in this trial.

Eligibility Criteria

Inclusion Criteria

  • Age between 1 and 30 years old.
  • Diagnosed with neuroblastoma or ganglioneuroblastoma with specific characteristics.
  • Classified as high risk according to certain medical guidelines.
  • Must have experienced a return or progression of the disease after initial treatment, or have persistent or refractory disease after at least four courses of therapy.
  • Must show MIBG uptake in at least one tumor site within 21 days before starting the study.
  • Must have a certain number of stem cells available for treatment.
  • Must have a performance score indicating they can perform daily activities.
  • Must have recovered from previous treatments and have adequate organ function, including blood, kidney, liver, and heart function.
  • Must not have active central nervous system disease.
  • Females of childbearing age must have a negative pregnancy test and agree to use birth control.

Exclusion Criteria

  • Pregnant or breastfeeding women, or those unwilling to use birth control.
  • Patients unable to comply with study requirements.
  • Patients with major organ disease that affects treatment tolerance.
  • Previous allogeneic stem cell transplant or solid organ transplant recipients.
  • Previous total body irradiation recipients.
  • Patients on hemodialysis.
  • Patients with active or uncontrolled infections.
  • Patients with a history of certain viral infections.
  • Patients who had to stop certain therapies due to side effects.
  • Patients who have had specific previous treatments with MIBG.
  • Patients with a history of deep vein thrombosis not related to a catheter.
  • Patients who do not wish to participate in related studies.
  • Patients with non-MIBG avid disease or progressive disease after previous MIBG therapy.
  • Patients who have received a high cumulative dose of MIBG.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.