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NCT00033293 · ClinicalTrials.gov registry record · Phase 3
Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT00033293: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00033293 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00033293, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma.
Primary Outcome
A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Magnetic Resonance Imaging
- OTHER Laboratory Biomarker Analysis
- DRUG Prednisone
- OTHER Clinical Observation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2004-03-15 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 3 |
What the finished NCT00033293 record still lists
NCT00033293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00033293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00033293 about?
NCT00033293 is a clinical study titled "Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma". This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in differ...
What is the current status of trial NCT00033293?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2004-03-15. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT00033293?
The interventions under investigation include: Cyclophosphamide (DRUG), Magnetic Resonance Imaging (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Prednisone (DRUG), Clinical Observation (OTHER).
Who is sponsoring clinical trial NCT00033293?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00033293's enrollment target sits among peer trials
53 1839th of 2000 higher than 160 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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