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NCT01175356 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Ganglioneuroblastoma and Localized Resectable Neuroblastoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
- 20
- Study locations
NCT01175356: Completed Phase 1 study of Ganglioneuroblastoma and Localized Resectable Neuroblastoma, sponsored by Children's Oncology Group.
NCT01175356 is a Phase 1 study of Ganglioneuroblastoma and Localized Resectable Neuroblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 99 participants, below the 1,450-participant average among 8 other Ganglioneuroblastoma trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01175356, a Phase 1 study of Ganglioneuroblastoma and Localized Resectable Neuroblastoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2011-12-21 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What the finished NCT01175356 record still lists
NCT01175356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,450-participant average among 8 other Ganglioneuroblastoma trials with a reported enrollment target (93% lower).
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.
NCT01175356 names 20 study sites across 15 states, led by California, Alabama, North Carolina.
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.
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).
Who is sponsoring clinical trial NCT01175356?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Ganglioneuroblastoma
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 NCT01175356's enrollment target sits among peer trials
99 4th of 8 higher than 5 of 8 other Ganglioneuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ganglioneuroblastoma 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.
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