Status:
COMPLETED
A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
Lead Sponsor:
Celldex Therapeutics
Conditions:
Glioblastoma
Small Cell Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This Phase II study will enroll patients into three groups. Group 1 are patients who have never been treated with bevacizumab. These patients will be randomly assigned to receive either rindopepimut/G...
Eligibility Criteria
Inclusion
- Among other criteria, patients must meet the following conditions to be eligible for the study:
- Age ≥18 years of age.
- Histologic diagnosis of glioblastoma (WHO Grade IV).
- Documented EGFRvlll positive tumor status (central lab confirmation).
- First or second relapse of de novo glioblastoma or first diagnosis or first relapse of secondary glioblastoma.
- Previous treatment must include surgery, conventional radiation therapy and temozolomide (TMZ).
- Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy.
- KPS of ≥ 70%.
- If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of dexamethasone or equivalent per day during the week prior to Day 1.
- Evaluable disease in Groups 1 and 2; measurable disease in Group 2C
- Life expectancy \> 12 weeks.
- Patients in Group 2 and 2C must have had disease progression while receiving bevacizumab or within 2 months of treatment with bevacizumab.
Exclusion
- Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- Subjects unable to undergo an MRI with contrast.
- History, presence, or suspicion of metastatic disease
- Prior receipt of vaccination against EGFRvIII.
- Any known contraindications to receipt of study drugs, including known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
- Use of non-protein based investigational therapy within 14 days prior to Day 1 or use of antibody-based investigational therapy within 28 days prior to Day 1.
- Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- Evidence of recent hemorrhage on screening MRI of the brain
- Evidence of current drug or alcohol abuse.
- Patients in Group 1 must not have received prior treatment with bevacizumab.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2016
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01498328
Start Date
December 1 2011
End Date
May 17 2016
Last Update
February 17 2020
Active Locations (45)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
St. Joseph's Hospital and Medical Center / Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
3
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
4
University of Southern California (USC) Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089