Zoledronic Acid (ZOMETA) With Cyclophosphamide With Neuroblastoma and Cortical Bone Involvement
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.
Timeline
- Start
- 2005-04
- Primary completion
- 2008-04
- Completion
- 2013-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 25 mg/m2 | Oral |
| Subject | Zoledronic acid | Other / unclassified | 2 mg/m2 | Intravenous |