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

Celldex Therapeutics

Status and phase

Completed

Phase 2

Conditions

Malignant Glioma

Treatments

Drug: Temozolomide

Drug: CDX-110 with GM-CSF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00458601

CDX110-003

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.