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COMPLETED Phase 2

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

NCT01767194 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 73 participants
Start Date 2013-02-12
Est. Completion 2022-09-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01767194

The ClinicalTrials.gov registry entry for NCT01767194 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01767194 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arkansas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01767194?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial