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

Celldex Therapeutics82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Glioma

Interventions

CDX-110 with GM-CSFDRUG

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.

TemozolomideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

Progression-free survival status

Time frame: 5.5mo

Secondary Outcomes

Safety and tolerability characterized by adverse events (term, grade, frequency).

Time frame: 2 years

Safety and tolerability characterized by physical examinations.

Time frame: 2 years

Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).

Time frame: 2 years

Safety and tolerability characterized by urinalysis.

Time frame: 2 years

Safety and tolerability characterized by vital signs.

Time frame: 2 years

Immune response; T-cell response to vaccine.

Time frame: 2 years

Immune response; antibody response to vaccine.

Time frame: 2 years

Immune response; HLA typing.

Time frame: 2 years

Overall survival.

Time frame: indeterminate

Data from ClinicalTrials.gov

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Celldex Investigational Site

Orange, California, United States

Celldex Investigational Site

San Francisco, California, United States

Celldex Investigational Site

San Francisco, California, United States

Celldex Investigational Site

Stanford, California, United States

Celldex Investigational Site

Stanford, California, 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

Gainesville, Florida, United States

Celldex Investigational Site

Chicago, Illinois, United States

...and 24 more locations