Clinical trialNCT00969722TerminatedPhase 2Interventional

A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients

SponsorUnited TherapeuticsEnrollment1Primary Refractory Neuroblastoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two cycles may cross-over to receive the alternate treatment. Disease response and safety will be assessed in all patients after cycle 2 and after cycle 4.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Peter E. Zage, M.D.
M.D. Anderson Cancer Center
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Phoenix Children'S Hospital
Phoenix, Arizona, United States
Rady Children'S Hospital of San Diego
San Diego, California, United States
Georgetown Medical Center
Washington D.C., District of Columbia, United States
All Children'S Hospital in Florida
St. Petersburg, Florida, United States
Lsu Health Sciences Center; Children'S Hospital
New Orleans, Louisiana, United States
Children'S Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Children'S Hospital at Montefiore
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Nationwide Childrens Hospital
Columbus, Ohio, United States
University of Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States
Children'S Hospital of Pittsburgh of Upmc
Pittsburgh, Pennsylvania, United States
Us Oncology
Dallas, Texas, United States
the University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Vermont Cancer Center
Burlington, Vermont, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Isotretinoin →MAb-3F8Subcutaneous Granulocyte Macrophage Colony Stimulating Factor

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2009
Primary completion: 31 Aug 2010
Completion: —
Last update posted: 8 Mar 2013
Registered enrollment: 1
Registry id: NCT00969722

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.