A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

Conditions

• Giant Cell Glioblastoma
• Glioblastoma
• Glioblastoma With Oligodendroglial Component
• Gliosarcoma
• Recurrent Glioblastoma
• Relapsed Glioblastoma
• Small Cell Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  A vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period.
• Rindopepimut (CDX-110) with GM-CSF — DRUG
  Rindopepimut/GM-CSF will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM-CSF.
• KLH — DRUG
  KLH will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 100 mcg of KLH.

Study Details

The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.

Key Dates

First listed

Dec 23, 2011

Start date

Dec 31, 2011

Status verified

Apr 2017

Primary completion

Apr 30, 2015

Completion

May 17, 2016

Study Design

Enrollment

127 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut.
  About half of the patients who have never received treatment with bevacizumab will receive rindopepimut/GM-CSF in a blinded fashion in combination with bevacizumab.
• Experimental: Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control
  About half of the patients who have never received treatment with bevacizumab will receive KLH in a blinded fashion in combination with bevacizumab.
• Experimental: Group 2 and 2C: Refractory to Bevacizumab
  Patients with progressive disease while currently on or within two months after discontinuing bevacizumab will be administered rindopepimut/GM-CSF while continuing (or restarting if they had stopped bevacizumab).

Primary Outcome Measure

Groups 1 and 2: Progression-free survival rate [ Time Frame: 6 months post-Day 1 ]

Locations (45)

Find similar trials in Birmingham, AL

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