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ACTIVE NOT RECRUITING
NCT03786783
PHASE2

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II pilot trial studies the side effects and how well dinutuximab and sargramostim work when combined with chemotherapy in patients with high-risk neuroblastoma. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Sargramostim helps the body produce normal infection-fighting white blood cells. These cells also help the dinutuximab work better. Giving chemotherapy before a stem cell transplant, with drugs such as cisplatin, etoposide, vincristine, doxorubicin, cyclophosphamide, thiotepa, melphalan, etoposide, carboplatin, topotecan, and isotretinoin, helps kill cancer cells that are in the body and helps make room in a patient's bone marrow for new blood-forming cells (stem cells). Giving dinutuximab and sargramostim with combination chemotherapy may work better than combination chemotherapy alone in treating patients with high-risk neuroblastoma.

Official title: A Pilot Induction Regimen Incorporating Chimeric 14.18 Antibody (ch14.18, Dinutuximab) (NSC# 764038) and Sargramostim (GM-CSF) for the Treatment of Newly Diagnosed High-Risk Neuroblastoma

Key Details

Gender

All

Age Range

Any - 30 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2019-03-04

Completion Date

2026-09-19

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo ASCT

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Dexrazoxane

Given IV

BIOLOGICAL

Dinutuximab

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Etoposide

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

DRUG

Isotretinoin

Given PO

DRUG

Melphalan

Given IV

BIOLOGICAL

Sargramostim

Given SC

DRUG

Thiotepa

Given IV

DRUG

Topotecan

Given IV

DRUG

Vincristine

Given IV

Locations (10)

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Royal Children's Hospital

Parkville, Victoria, Australia

Starship Children's Hospital

Grafton, Auckland, New Zealand