NCT00969722

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

A Randomized Study of Monoclonal Antibody 3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Compared to 13-cis-Retinoic Acid Plus GM-CSF in High Risk Stage 4, Primary Refractory Neuroblastoma Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Months – 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Refractory Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	MAb-3F8
BIOLOGICAL	Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
BIOLOGICAL	13-cis-Retinoic Acid

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• First posted: 2009-09-01
• Last updated: 2013-03-08

Locations

15 sites across 1 country: United States