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ACTIVE NOT RECRUITING Phase 1

Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma

NCT01711554 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as lenalidomide and isotretinoin, 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. Monoclonal antibodies, such as dinutuximab, may interfere with the ability of tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together with dinutuximab therapy may kill more tumor cells.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Lenalidomide
  • DRUG Isotretinoin
  • OTHER Pharmacological Study
  • BIOLOGICAL Dinutuximab

Study Locations (15)

California

  • Children's Hospital Los Angeles — Los Angeles
  • Lucile Packard Children's Hospital Stanford University — Palo Alto
  • UCSF Medical Center-Parnassus — San Francisco

Massachusetts

  • Boston Children's Hospital — Boston
  • Dana-Farber Cancer Institute — Boston

Colorado

  • Children's Hospital Colorado — Aurora

Georgia

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta

Illinois

  • University of Chicago Comer Children's Hospital — Chicago

Michigan

  • C S Mott Children's Hospital — Ann Arbor

North Carolina

  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2013-02-04
Est. Completion 2027-03-03
Phase Phase 1

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 NCT01711554

The ClinicalTrials.gov registry entry for NCT01711554 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 27 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 Refractory 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: NCT01711554 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, 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 NCT01711554 about?

NCT01711554 is a clinical study titled "Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma". This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as lenalidomide and i...

What is the current status of trial NCT01711554?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2013-02-04. Estimated completion is 2027-03-03.

What conditions does trial NCT01711554 study?

This clinical trial studies the following conditions: Refractory Neuroblastoma, Recurrent Neuroblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01711554?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Isotretinoin (DRUG), Pharmacological Study (OTHER), Dinutuximab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01711554?

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 NCT01711554 being conducted?

This trial has 15 study locations across California, Colorado, Georgia, Illinois, Massachusetts. 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