Dendritic cell-based Immunotherapy in patients with primary glioblastoma multiforme

Dendritic cell-based Immunotherapy in patients with primary glioblastoma multiforme -Phase I/IIa clinical trial-

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000280

Enrollment

Registered

2011-11-28

Start date

2011-12-20

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 : Biological: Autologous Dendritic Cell(CreaVax-BC) Dosage: 1 x 10^7 cell/Injection Frequency: CreaVax-BC given by jugular regional lymph node injection 4 times ev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
evaluation of immune response (T cell Proliferation assay, ELISPOT ASSAY);Adverse event, lab test, vital sign, Chest X-ray, physical and examination	—

Secondary

Measure	Time frame
tumor response rate, time to progression, overall survival, DTH	—

Countries

Korea, Republic of

Contacts

Public ContactMinkyu Heo

JW CreaGene

Outcome results