Dendritic cell-based Immunotherapy in patients with primary glioblastoma multiforme
- Conditions
- Neoplasms
- Registration Number
- KCT0000280
- Lead Sponsor
- Bundang CHA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 13
1. Among patients with glioblastoma(WHO Grade IV) by histological examination, a patient conformed state by resectable treatment including biopsy and having a plan to receive radiotherapy.
2. A patient aged over 20, until 70
3. KPS > 60
4. A patient over 3 months survival expected
5. A patinet wired up cancer antigen which is needed to make
investigational drug before starting clinical trial
6. Hemoglobin > 10.0 g/dL, WBC > 3,500/µL, PLT > 100,000/µL
Creatinine = 1.5 times of normal upper limit
SGOT/SGPT = 3 times of normal upper limit
7. A patient who signed the written consent form by oneself
1. A patient with cardiopulmonary disability judged by the investigator
2. A patinet needed antibiotic treatment due to serious infection, HIV infection
3. A patinet with heart, liver, lung or kidney disability
4. A patient with the medical history of autoimmune disease or with immunodeficiency or autoimmune disease that might be aggravated by immunotherapy
5. A pregnant woman, breast-feeding woman or woman who wants to be pregnant during the trial period
6. A patient with uncontrolled hypertension or hypotension
7. A patient can't have dopamine or other pressor-agents
8. A patient with hypersensitivity reaction about phosphoprotein including interleukin-2
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evaluation of immune response (T cell Proliferation assay, ELISPOT ASSAY);Adverse event, lab test, vital sign, Chest X-ray, physical and examination
- Secondary Outcome Measures
Name Time Method tumor response rate, time to progression, overall survival, DTH