A Multi-Centered, Open, Randomized, Phase I/II Study on The Efficacy and Safety of CreaVax-BC (Autologous Dendritic Cells) in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients
- Conditions
- Neoplasms
- Registration Number
- KCT0003302
- Lead Sponsor
- JW CreaGene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
1. Patients who underwent the surgery for treatment and are eligible for leukapheresis before receiving combined radiation therapy and chemotherapy (CCRT) to treat glioblastoma
2. Newly and histologically diagnosed with glioblastoma (WHO grade IV)
3. Men or women who are at the age of =20 years and <70 years
4. Karnofsky Index > 60%
5. Life expectancy = 3 months
6. Patients with enough tumor antigens for IP production
7. Normal renal, liver, and bone marrow function
- complete blood cell count: Hb = 10.0 g/dL, WBC = 3,500/µL, PLT = 100,000/µL
- serum creatinine = 1.5 the upper limit of normal
- serum SGOT/SGPT = 3 the upper limit of normal
8. Signed informed consent voluntarily
1. Patients who have not had a surgery for the treatment or are not histologically diagnosed with glioblastoma upon the surgery
2. Active infection in the opinion of the investigator: septicemia, HIV
3. Significant organ (liver, lung, cardiac) dysfunction in the opinion of the investigator
4. History of another malignancy within last 5 years, except for glioblastoma
5. Non-controlled hypotension or hypertension
6. Patients who received any other investigational products within last 4 weeks
7. Pregnant or lactating women. Women of childbearing potential and sexually active male participants must agree to use reliable methods of contraception during the study period.
8. Patients who cannot undergo MRI
9. Others who are judged by the investigator to be ineligible for the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event(NCI CTCAE);Physical examination;Laboratory test;Echocardiogram;Progression free survival
- Secondary Outcome Measures
Name Time Method Overall Survival rate;Time to Progression;Disease controll rate (Complete Response + Partial Response +Stable Disease, %);Quality of life;Cell Based Immune Response