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| Diagnosis | High Risk, Recurrent, or Refractory Neuroblastoma | Study Status | Open |
| Phase | II |
| Age | 1 Year and older | Randomisation | YES |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Biological: Dinutuximab (Given Intravenous (IV))
Drug: Irinotecan Hydrochloride (Given Intravenous (IV))
Biological: Sargramostim (Given Intravenous (IV) or Subcutaneous (SC))
Drug: Temozolomide (Given orally or via NG or G tube)
Drug: Eflornithine Hydrochloride (Given orally or via NG or G tube) may or may not be given |
| Last Posted Update | 2023-09-28 |
| ClinicalTrials.gov # | NCT03794349 |
International Sponsor
Children's Oncology GroupPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
CancerCare Manitoba - Dr. Ashley Chopek
CHU Quebec - Dr. Bruno Michon
CHU Sherbrooke - Dr. Josée Brossard
Hamilton Health Sciences Centre (McMaster) - Dr. Uma H. Athale
IWK Health Centre - Dr. Craig Erker
Montreal Children's Hospital - Dr. Sharon Abish Centres
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson
Medical contact
Raoul Santiago
Social worker/patient navigator contact
Isabelle Audet
Clinical research contact
Barbara Desbiens
Medical contact
Dr. Carol Portwine
Social worker/patient navigator contact
Jane Cassano
Clinical research contact
Sabrina Millson
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez
Dr. Ketan Kulkarni
Social worker/patient navigator contact
Rhonda Brophy
Clinical research contact
Tina Bocking
Medical contact
Dr. Josee Brossard
Social worker/patient navigator contact
Please Contact Site Directly
Clinical research contact
Please Contact Site Directly
Study Description
This is a phase II study to treat patients with neuroblastoma that has come back (relapsed) or is not responding to previous treatment (refractory). This study is seeing if combining eflornithine (a drug used to block the production of chemicals that may cause growth of cancer cells) with drugs used in chemotherapy/immunotherapy (irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab) may work better in treating patients with relapsed or refractory neuroblastoma compared to using irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab alone. Patients will be randomly assigned to 1 of 2 regimens, one regimen will recieve eflornithine with the chemotherapy/immunotherapy drugs and the other regimen will recieve chemotherapy/immunotherapy drugs without eflornithine.
Inclusion Criteria
- Patients must have a neuroblastoma that has come back, progressed or not responded to previous treatment
- Patients must be 1 year of age or older
- Patients must be up and about at least 50% of their waking hours
- 14 days must have passed if patients have recieved any treatment that supresses bone marrow
- >= 21 days must have passed from infusion of antibodies
- Patients must not have received radiation for a minimum of 4 weeks before joining the study. Palliative radiation while on study is not permitted.
- Blood work must come back within the acceptable ranges
- Patients must have no evidence of shortness of breath, and no need for supportive oxygen
- Patients with a history of central nervous system (CNS) disease must have no evidence of active CNS disease at the time of study enrollment
- Patients with seizure disorders may be enrolled if seizures are well controlled on proper medication
- Patients of childbearing potential must have a negative pregnancy test to be eligible for this study and must agree to use adequate contraception while enrolled on this study.
Other inclusion and exclusion criteria may apply and will be reviewed by your treating team.
