Study on Dinutuximab, Sargramostim, and Chemotherapy for Newly Diagnosed High-Risk Neuroblastoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03786783

Provider View

This clinical trial is exploring the effects of combining dinutuximab and sargramostim with chemotherapy to treat patients with high-risk neuroblastoma, a type of cancer that affects nerve cells. The study aims to see if this combination can improve treatment outcomes compared to chemotherapy alone.

Patient Parameters

Program Overview

This study is testing a new treatment approach for high-risk neuroblastoma, a cancer that affects nerve cells, often in children. The treatment combines dinutuximab, an immunotherapy drug, with sargramostim, which helps boost the immune system, and standard chemotherapy. The goal is to see if this combination can better control the cancer and improve survival rates compared to chemotherapy alone. The study will also look at how well patients tolerate the treatment and how it affects their immune system.

Description

The main goal of this study is to see if combining dinutuximab and sargramostim with chemotherapy is safe and can be tolerated by patients with newly diagnosed high-risk neuroblastoma. The study will also look at how well this combination works in controlling the cancer and improving survival rates.

The treatment plan includes several phases:

  • Induction Phase: Patients will receive a series of chemotherapy cycles, with dinutuximab and sargramostim added during cycles 3 to 5. This phase aims to reduce the cancer as much as possible before moving to the next stage.

  • Consolidation Phase: After the induction phase, patients will undergo two rounds of high-dose chemotherapy followed by a stem cell transplant to help restore healthy blood cells.

  • Radiation Therapy: Patients will receive radiation therapy to target any remaining cancer cells.

  • Post-Consolidation Therapy: This phase includes additional treatment with dinutuximab, sargramostim, and isotretinoin to help prevent the cancer from returning.

Patients will be closely monitored throughout the study to assess their response to the treatment and any side effects. Follow-up visits will continue for several years after the treatment to track long-term outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in specific related studies before joining this trial.
  • Must have a confirmed diagnosis of neuroblastoma or ganglioneuroblastoma.
  • Eligible if they have certain high-risk features, such as specific genetic markers or age criteria.
  • Must not have received prior systemic therapy for high-risk disease, except in specific emergency situations.
  • Must have adequate kidney, liver, and heart function as determined by specific medical tests.
  • Must be able to undergo stem cell collection if needed.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Patients over 18 months old with certain lower-risk features are not eligible.
  • Patients with bone marrow failure syndromes are not eligible.
  • Patients on certain immunosuppressive medications are not eligible.
  • Pregnant or breastfeeding females are not eligible due to potential risks to the baby.
  • Sexually active patients must agree to use effective contraception during the study and for two months after the last dose of dinutuximab.

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