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A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma (ReACT)
Complete title: A Phase II Study of Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma
|Research Study Number||20111765|
|Principal Investigator||Maciej Mrugala, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
Among other criteria, patients must meet the following conditions to be eligible for the study:
- 1.) Age >/= 18 years of age.
- 2.) Histologic diagnosis of glioblastoma (WHO Grade IV).
- 3.) Previous treatment for glioblastoma must include surgery,conventional radiation therapy and temozolomide (TMZ).
- 4.0 First or second relapse of de novo glioblastoma.
- 5.) Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy.
- 6.) KPS of >/= 70%.
- 7.) Life expectancy > 12 weeks.
- 8.) Documented EGFRvIII positive tumor status by a Sponsor designated laboratory.
- 9.) 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.
- 10.) Evaluable disease
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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 shellfish proteins.
- 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.
Other exclusion criteria may apply.
Glioblastoma Multiforme; Solid Tumors
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