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NCT01767194 · ClinicalTrials.gov registry record · Phase 2
Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma
A Phase 2 study of Recurrent Neuroblastoma and Ganglioneuroblastoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
- 20
- Study locations
NCT01767194: Completed Phase 2 study of Recurrent Neuroblastoma and Ganglioneuroblastoma, sponsored by National Cancer Institute (NCI).
NCT01767194 is a Phase 2 study of Recurrent Neuroblastoma and Ganglioneuroblastoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 73 participants, below the 1,132-participant average among 9 other Recurrent Neuroblastoma trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01767194, a Phase 2 study of Recurrent Neuroblastoma and Ganglioneuroblastoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.
Primary Outcome
The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \>90% decrease of the disease measurement for CT/MRI target lesion
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temozolomide
- DRUG Irinotecan Hydrochloride
- BIOLOGICAL Sargramostim
- BIOLOGICAL Dinutuximab
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Valley Children's Hospital - Madera
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Parnassus - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Arizona
- Phoenix Childrens Hospital - Phoenix
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2013-02-12 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 2 |
What the finished NCT01767194 record still lists
NCT01767194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,132-participant average among 9 other Recurrent Neuroblastoma trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Recurrent Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01767194 names 20 study sites across 6 states, led by California, Arkansas, Colorado.
Frequently Asked Questions
What is clinical trial NCT01767194 about?
NCT01767194 is a clinical study titled "Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma". This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozol...
What is the current status of trial NCT01767194?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2013-02-12. Estimated completion is 2022-09-30.
What conditions does trial NCT01767194 study?
This clinical trial studies the following conditions: Recurrent Neuroblastoma, Ganglioneuroblastoma.
What interventions are being tested in trial NCT01767194?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Irinotecan Hydrochloride (DRUG), Sargramostim (BIOLOGICAL), Dinutuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01767194?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01767194 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01767194's enrollment target sits among peer trials
73 7th of 9 higher than 3 of 9 other Recurrent Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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