Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
- Conditions
- Health Condition 1: null- Glioblastoma
- Registration Number
- CTRI/2012/07/002822
- Lead Sponsor
- ovotech Clinical Research India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 440
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 <=2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
WHO-ECOG Performance Status <= 2
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall SurvivalTimepoint: During treatment and every three months from end of treatment through end of study or approximately up to 5 years
- Secondary Outcome Measures
Name Time Method 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