Zoledronic Acid (ZOMETA) With Cyclophosphamide With Neuroblastoma and Cortical Bone Involvement
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborator:
New Approaches to Neuroblastoma Therapy Consortium