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

Phase 2

Completed

• Conditions: Malignant Glioma
• Interventions: Drug: CDX-110 with GM-CSF; Drug: Temozolomide

• Registration Number: NCT00458601
• Lead Sponsor: Celldex Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-10
• Study First Submitted QC: 2007-04-10
• Study First Posted: 2007-04-11
• Study Start: 2007-08
• Disposition First Submitted: 2010-06-24
• Disposition First Submitted QC: 2010-07-16
• Disposition First Posted: 2010-07-20
• Primary Completion: 2010-11
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
• Gross total resection followed by conventional chemoradiation therapy without progression of disease.

Exclusion Criteria

• Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
• Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
• Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
• Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CDX-110 with GM-CSF	Temozolomide	-
CDX-110 with GM-CSF	CDX-110 with GM-CSF	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival status	5.5mo

Secondary Outcome Measures

Name	Time	Method
Immune response; T-cell response to vaccine.	2 years
Immune response; HLA typing.	2 years
Safety and tolerability characterized by adverse events (term, grade, frequency).	2 years
Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).	2 years
Safety and tolerability characterized by physical examinations.	2 years
Immune response; antibody response to vaccine.	2 years
Safety and tolerability characterized by urinalysis.	2 years
Safety and tolerability characterized by vital signs.	2 years
Overall survival.	indeterminate

Trial Locations

Locations (1)

Celldex Investigational Site; 🇺🇸 Seattle, Washington, United States