ANBL1821 : A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

1+Age Over 1

Brain and Spinal<br/>CancersCancer LocationBrain and Spinal
Cancers

Systemic therapy,Treatment | Brain and spinal cordNeuroblastoma

Trial Overview Read MoreRead more

This phase II trial is evaluating a combination of chemotherapy and immunotherapy treatments in patients with neuroblastoma that has come back or not responded to prior treatment.
 

This trial is treating patients with neuroblastoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

Cooperative Group

Children's Oncology Group

Other Non-Commercial Sponsor

National Cancer Institute (NCI)

Summary

ELigible patients will be randomised to 1 of 2 regimens. In Regimen A, patients receive temozolomide orally, via nasogastric, or gastric tube on days 1-5, irinotecan hydrochloride intravenously over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim subcutaneously or intravenously over 2 hours on days 6-12 of a 21-day cycle. Treatment in this regimen will be repeated every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. In Regimen B, patients will receive eflornithine orally, via nasogastric, or gastric tube on days -6 to 7 and days 15-21 of cycle 1 orally, via nasogastric, or gastric tube on days 1-5, irinotecan hydrochloride intravenously over 90 minutes on days 1-5, dinutuximab intravenously over 10-20 hours on days 2-5, and sargramostim subcutaneously or intravenously over 2 hours on days 6-12. Treatment in this regimen will last for 28 days for cycle 1 and then every 21 days for subsequent cycles. Up to 17 cycles will be administered in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and periodically for 5 years.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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