Trial Search Results
A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
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.
Stanford is currently not accepting patients for this trial.
- Drug: Bevacizumab
- Drug: Rindopepimut (CDX-110) with GM-CSF
- Drug: KLH
Among other criteria, patients must meet the following conditions to be eligible for the
1. Age ≥18 years of age.
2. Histologic diagnosis of glioblastoma (WHO Grade IV).
3. Documented EGFRvlll positive tumor status (central lab confirmation).
4. First or second relapse of de novo glioblastoma or first diagnosis or first relapse of
5. Previous treatment must include surgery, conventional radiation therapy and
6. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at
least 12 weeks after radiation therapy.
7. KPS of ≥ 70%.
8. 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.
9. Evaluable disease in Groups 1 and 2; measurable disease in Group 2C
10. Life expectancy > 12 weeks.
11. Patients in Group 2 and 2C must have had disease progression while receiving
bevacizumab or within 2 months of treatment with bevacizumab.
Among other criteria, patients who meet the following conditions are NOT eligible for the
1. Subjects unable to undergo an MRI with contrast.
2. History, presence, or suspicion of metastatic disease
3. Prior receipt of vaccination against EGFRvIII.
4. 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
5. 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.
6. Clinically significant increased intracranial pressure (e.g., impending herniation),
uncontrolled seizures, or requirement for immediate palliative treatment
7. Evidence of recent hemorrhage on screening MRI of the brain
8. Evidence of current drug or alcohol abuse.
9. Patients in Group 1 must not have received prior treatment with bevacizumab.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study