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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 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.

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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

Neuroblastoma

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

FieldValue
Enrollment Target 21 participants
Start Date 2005-04
Est. Completion 2013-05
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

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What the Registry Record Tells You About NCT00206388

The ClinicalTrials.gov registry entry for NCT00206388 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (91% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.