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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003302

Enrollment

Registered

2018-10-29

Start date

2017-12-18

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : The investigational products (CreaVax-BC, Autologous dendritic cells) are generated from the patients with glioblastoma through leukapheresis. Patients who are ra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Adverse event(NCI CTCAE);Physical examination;Laboratory test;Echocardiogram;Progression free survival	—

Secondary

Measure	Time frame
Overall Survival rate;Time to Progression;Disease controll rate (Complete Response + Partial Response +Stable Disease, %);Quality of life;Cell Based Immune Response	—

Countries

Korea, Republic of

Contacts

Public ContactSojung Hwang

Bundang CHA General Hospital

sjhwang7@chamc.co.kr+82-31-780-5323

Outcome results