NCT00458601

Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme

A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
DRUG	CDX-110 with GM-CSF	Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
DRUG	Temozolomide	Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-11-01
• Completion: 2016-05-01
• First posted: 2007-04-11
• Last updated: 2018-01-16

Locations

34 sites across 1 country: United States