Health Condition 1: null- Glioblastoma
Conditions
Interventions
Intervention1: Rindopepimut/GM-CSF plus Temozolomide: Drug: Rindopepimut (CDX-110) with GM-CSF
Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or int
Sponsors
Novotech Clinical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Among other criteria, patients must meet the following conditions to be eligible for the study: Adult patients, >= 18 years old Newly diagnosed glioblastoma Attempted surgical resection followed by conventional chemoradiation Documented EGFRvIII positive tumor status by a Sponsor designated laboratory No unequivocal radiographic progression of disease during the pre-study chemoradiation period. Systemic corticosteroid therapy at WHO-ECOG Performance Status <= 2
Exclusion criteria
Exclusion criteria: Among other criteria, patients who meet the following conditions are NOT eligible for the study: Stereotactic biopsy only (without further surgical resection) Presence of diffuse leptomeningeal disease or gliomatosis cerebri History, presence, or suspicion of metastatic disease Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide Active systemic infection requiring treatment History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer or cured, early-stage prostate cancer in a patient with PSA level less than the upper limit of normal Planned major surgery Evidence of current drug or alcohol abuse 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: During treatment and every three months from end of treatment through end of study or approximately up to 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survivalTimepoint: Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy;Safety and TolerabilityTimepoint: Until day 28 of follow up | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Greece, Hungary, India, Mexico, New Zealand, Peru, Poland, Serbia, Taiwan, Thailand, United States of America
Contacts
Public ContactSushma Srikanth
Novotech Clinical Research India Private Limited
Outcome results
None listed