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Monoclonal Antibodies

Dinutuximab for Ganglioneuroblastoma

Phase 2
Waitlist Available
Led By Rajen Mody
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing how well two drugs, irinotecan hydrochloride and temozolomide, work with either temsirolimus or dinutuximab in treating neuroblastoma in younger patients.

Eligible Conditions
  • Ganglioneuroblastoma
  • Neuroblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients in the Dinutuximab Arm Who Are Responders
Percentage of Randomized Patients Who Are Responders
Other outcome measures
Ability to Maintain Intended Treatment Without a Dose Reduction or Going Off Protocol Therapy for Toxicity
Occurrence of Unacceptable Toxicities
Overall Response
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (temozolomide, irinotecan hydrochloride, dinutuximab)Experimental Treatment5 Interventions
Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.
Group II: Arm I (temozolomide, irinotecan hydrochloride, temsirolimus)Experimental Treatment4 Interventions
CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dinutuximab
2009
Completed Phase 3
~710
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Temozolomide
2010
Completed Phase 3
~1930
Temsirolimus
2008
Completed Phase 2
~1940
Sargramostim
2008
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,080 Total Patients Enrolled
11 Trials studying Ganglioneuroblastoma
12,274 Patients Enrolled for Ganglioneuroblastoma
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,314 Total Patients Enrolled
Rajen ModyPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
Irinotecan, Temozolomide, and Dinutuximab with GM-CSF in Children with Refractory or Relapsed Neuroblastoma: A Report from the Children’s Oncology Group
Mody, Rajen, Alice L. Yu, Arlene Naranjo, Fan F. Zhang, Wendy B. London, Barry L. Shulkin, Marguerite T. Parisi, et al.. 2020. “Irinotecan, Temozolomide, and Dinutuximab with GM-CSF in Children with Refractory or Relapsed Neuroblastoma: A Report from the Children’s Oncology Group”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.00203.
The Lancet OncologyJournal
Irinotecan–temozolomide with Temsirolimus or Dinutuximab in Children with Refractory or Relapsed Neuroblastoma (COG ANBL1221): An Open-label, Randomised, Phase 2 Trial
Mody, Rajen, Arlene Naranjo, Collin Van Ryn, Alice L Yu, Wendy B London, Barry L Shulkin, Marguerite T Parisi, et al.. 2017. “Irinotecan–temozolomide with Temsirolimus or Dinutuximab in Children with Refractory or Relapsed Neuroblastoma (COG ANBL1221): An Open-label, Randomised, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(17)30355-8.
clinicaltrials.govStudy
Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma
2013. "Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01767194.
~6 spots leftby Apr 2025
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