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Zoledronic Acid (ZOMETA) With Cyclophosphamide With Neuroblastoma and Cortical Bone Involvement

NCT00206388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-08-02

No results posted yet for this 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

Interventions

DRUG

Zolendric acid

IV, 2mg/m2/dose on day 0

DRUG

Cyclophosphamide

fixed dose of 25mg/m2/dose days 0-27

Sponsors & Collaborators

  • New Approaches to Neuroblastoma Therapy Consortium

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Peter Zage, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-04-30
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00206388 on ClinicalTrials.gov