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COMPLETED Phase 1

Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

NCT01175356 · View on ClinicalTrials.gov ↗

Study Summary

This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Cisplatin
  • DRUG Busulfan
  • PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
  • RADIATION 3-Dimensional Conformal Radiation Therapy

Study Locations (20)

California

  • Children's Hospital Los Angeles — Los Angeles
  • UCSF Medical Center-Parnassus — San Francisco
  • UCSF Medical Center-Mission Bay — San Francisco

Alabama

  • Children's Hospital of Alabama — Birmingham
  • University of Alabama at Birmingham Cancer Center — Birmingham

North Carolina

  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill
  • Duke University Medical Center — Durham

Texas

  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas
  • Cook Children's Medical Center — Fort Worth

Arizona

  • Phoenix Childrens Hospital — Phoenix

Colorado

  • Children's Hospital Colorado — Aurora

Connecticut

  • Connecticut Children's Medical Center — Hartford

District of Columbia

  • Children's National Medical Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2011-12-21
Est. Completion 2025-12-31
Phase Phase 1

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01175356

The ClinicalTrials.gov registry entry for NCT01175356 describes a study currently listed as completed. 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 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Ganglioneuroblastoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide 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: NCT01175356 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Alabama, North Carolina. 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 NCT01175356 about?

NCT01175356 is a clinical study titled "Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin". This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane ...

What is the current status of trial NCT01175356?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2011-12-21. Estimated completion is 2025-12-31.

What conditions does trial NCT01175356 study?

This clinical trial studies the following conditions: Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Stage 4 Neuroblastoma, Localized Unresectable Neuroblastoma, Regional 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 NCT01175356?

The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Busulfan (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), 3-Dimensional Conformal Radiation Therapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01175356?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01175356 being conducted?

This trial has 20 study locations across Alabama, Arizona, 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