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

Malignant Glioma Clinical Trial

— ACT III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458601
• Other study ID #: CDX110-003
• Secondary ID: CDX110-003
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2007
• Last updated: January 11, 2018
• Start date: August 2007
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2016
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Malignant Glioma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Celldex Investigational Site	Amherst	New York
United States	Celldex Investigational Site	Boston	Massachusetts
United States	Celldex Investigational Site	Charlottesville	Virginia
United States	Celldex Investigational Site	Chicago	Illinois
United States	Celldex Investigational Site	Cincinnati	Ohio
United States	Celldex Investigational Site	Cincinnati	Ohio
United States	Celldex Investigational Site	Cincinnati	Ohio
United States	Celldex Investigational Site	Cleveland	Ohio
United States	Celldex Investigational Site	Cleveland	Ohio
United States	Celldex Investigational Site	Durham	North Carolina
United States	Celldex Investigational Site	Evanston	Illinois
United States	Celldex Investigational Site	Gainesville	Florida
United States	Celldex Investigational Site	Hackensack	New Jersey
United States	Celldex Investigational Site	Houston	Texas
United States	Celldex Investigational Site	Lansing	Michigan
United States	Celldex Investigational Site	New Haven	Connecticut
United States	Celldex Investigational Site	New Haven	Connecticut
United States	Celldex Investigational Site	New Haven	Connecticut
United States	Celldex Investigational Site	New York	New York
United States	Celldex Investigational Site	New York	New York
United States	Celldex Investigational Site	Orange	California
United States	Celldex Investigational Site	Orange Village	Ohio
United States	Celldex Investigational Site	Philadelphia	Pennsylvania
United States	Celldex Investigational Site	Saginaw	Michigan
United States	Celldex Investigational Site	Saginaw	Michigan
United States	Celldex Investigational Site	Salt Lake City	Utah
United States	Celldex Investigational Site	San Antonio	Texas
United States	Celldex Investigational Site	San Francisco	California
United States	Celldex Investigational Site	San Francisco	California
United States	Celldex Investigational Site	Seattle	Washington
United States	Celldex Investigational Site	Stanford	California
United States	Celldex Investigational Site	Stanford	California
United States	Celldex Investigational Site	West Chester	Ohio
United States	Celldex Investigational Site	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Celldex Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schuster J, Lai RK, Recht LD, Reardon DA, Paleologos NA, Groves MD, Mrugala MM, Jensen R, Baehring JM, Sloan A, Archer GE, Bigner DD, Cruickshank S, Green JA, Keler T, Davis TA, Heimberger AB, Sampson JH. A phase II, multicenter trial of rindopepimut (CDX — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival status		5.5mo
Secondary	Safety and tolerability characterized by adverse events (term, grade, frequency).		2 years
Secondary	Safety and tolerability characterized by physical examinations.		2 years
Secondary	Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).		2 years
Secondary	Safety and tolerability characterized by urinalysis.		2 years
Secondary	Safety and tolerability characterized by vital signs.		2 years
Secondary	Immune response; T-cell response to vaccine.		2 years
Secondary	Immune response; antibody response to vaccine.		2 years
Secondary	Immune response; HLA typing.		2 years
Secondary	Overall survival.		indeterminate