Randomized phase IIb/III trial of autologous tumor vaccine with temozolomide for newly diagnosed glioblastoma.
Phase 2
- Conditions
- newly diagnosed glioblastoma
- Registration Number
- JPRN-UMIN000010602
- Lead Sponsor
- Tokyo Women's Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have been administered or are taking corticosteroid. 2) Patients who implantated of carmustine wafers in the surgical cavity. 3) Patients with high intracranical pressure. 4) Patients with severe myelosupression. 5) Patients with severe complication including hematopathy 6) Patients with malignant tumor or cancer except malignant glioma. 7) Pregnant or nursing woman, or woman willing to be pregnant. 8) Patients participate in other study during or within 6 months before temozolomide administration in this study. 9) Patients who has HBV or HCV. 10) Other reasons for exclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method 1) Cause-specific survival 2) Progression-free survival 3) Tumor-regression rate, disease-control rate 4) QOL 5) Neurological improvement