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A Phase I/II Clinical Trial Evaluating DC Activated Cytokine-induced Killer Cell(DCIK) Combined With DC Treatment for Glioma

Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Malignant Glioma

Thank you

Trial Information

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

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

Exclusion Criteria:

1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the

2. Presence of acute infection

3. Inability to obtain informed consent because of psychiatric or complicating medical

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the survival of malignant glioma

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Weicheng Yao

Investigator Role:

Study Chair

Investigator Affiliation:

2010 year


China: Ethics Committee

Study ID:




Start Date:

January 2011

Completion Date:

September 2013

Related Keywords:

  • Malignant Glioma
  • Glioma