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NCT00206388 · ClinicalTrials.gov registry record · Phase 1
Zoledronic Acid (ZOMETA) With Cyclophosphamide With Neuroblastoma and Cortical Bone Involvement
A Phase 1 study of Neuroblastoma, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 8
- Study locations
NCT00206388: Completed Phase 1 study of Neuroblastoma, sponsored by Baylor College of Medicine.
NCT00206388 is a Phase 1 study of Neuroblastoma that has completed, run by Baylor College of Medicine. The registered enrollment target is 21 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (91% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00206388, a Phase 1 study of Neuroblastoma, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purposes of this study are: 1. To find the highest dose of monthly intravenous Zometa that can be given with daily low doses of cyclophosphamide by mouth to children with recurrent or refractory neuroblastoma without causing severe side effects. 2. To find out the side effects seen by giving Zometa and cyclophosphamide on this schedule at different dose levels. 3. To measure blood and urine levels of Zometa during treatment 4. To preliminarily evaluate the antitumor activity of Zometa and concomitant oral cyclophosphamide in children with recurrent and/or refractory neuroblastoma within the confines of a Phase I study. 5. To measure the effects of Zometa on markers of bone breakdown found in urine, blood, and bone marrow 6. To measure the effects of Zometa on the immune system.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Zolendric acid
Study Locations (8)
California
- Children's Hospital Los Angeles - Los Angeles
- USCF School of Medicine - San Francisco
- Lucille Salter Packer Children's Hospital - Stanford
Indiana
- Indiana University-Riley Children's Hospital - Indianapolis
Ohio
- Cincinnati Children's Hospital - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Cancer Center - Houston
Wisconsin
- University of Wisconsin Medical Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2005-04 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT00206388 record still lists
NCT00206388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT00206388 lists 8 locations in 6 states (California, Indiana, Ohio).
Frequently Asked Questions
What is clinical trial NCT00206388 about?
NCT00206388 is a clinical study titled "Zoledronic Acid (ZOMETA) With Cyclophosphamide With Neuroblastoma and Cortical Bone Involvement". The purposes of this study are: 1. To find the highest dose of monthly intravenous Zometa that can be given with daily low doses of cyclophosphamide by mouth to children with recurrent or refractory neuroblastoma without causing severe side effects. 2. To find out the side effects seen by giving Zo...
What is the current status of trial NCT00206388?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2005-04. Estimated completion is 2013-05.
What conditions does trial NCT00206388 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT00206388?
The interventions under investigation include: Cyclophosphamide (DRUG), Zolendric acid (DRUG).
Who is sponsoring clinical trial NCT00206388?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00206388 being conducted?
This trial has 8 study locations across California, Indiana, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
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 NCT00206388's enrollment target sits among peer trials
21 71st of 94 higher than 23 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma 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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