A Phase I/II Clinical Trial Evaluating DC Activated Cytokine-induced Killer Cell(DCIK) Combined With DC Treatment for Glioma
Inclusion Criteria:
1. Female or male, adult patients of 18 to 70 years of age at time of diagnosis that
qualify for standard treatment including surgery and radiotherapy.
2. Histologically confirmed diagnosis of 1 of the following malignant gliomas:
Anaplastic astrocytoma Glioblastoma multiforme Oligodendroglioma Oligoastrocytoma
3. Newly diagnosed or recurrent disease
4. Patients must have had surgical resection at UCLA for the collection of their tumor.
Total, subtotal, or partial resection of more then 70% of tumor mass defined by MRI.
5. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV)
will need to be established.
6. Supratentorial tumour localisation.
7. Karnofsky performance status 60-100%
8. Life expectancy ≥ 12 weeks
9. Written informed consent of patient and/or legal guardian.
10. Must be off of steroid at least two weeks prior to vaccination
11. Hematologic and metabolic panel results will be within the parameters of the
protocol.
12. Negative pregnancy test
13. Fertile patients must use effective contraception
14. Hepatitis B negative
15. Hepatitis C negative
16. HIV negative
17. Syphilis serology negative
18. Patient must have no prior sensitivity to the components of the dendritic cell
vaccine.
Exclusion Criteria:
1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the
study,
2. Presence of acute infection
3. Inability to obtain informed consent because of psychiatric or complicating medical
problems.
4. Unstable or severe intercurrent medical or psychiatric conditions as determined by
the Investigator.
5. Subjects with organ allografts.
6. Contraindication to MRI
7. Known history of autoimmune disorder
8. Subjects who have an uncontrolled systemic malignancy that is not in remission.
9. Pregnancy or breast-feeding.
10. Positive for hepatitis B, C, HIV, syphilis
11. Patients unwilling to perform a save method of birth control.