Status:
UNKNOWN
Dendritic Cell (DC) Activated Cytokine-induced Killer Cell (DCIK) Combined With DC Treatment for Glioma
Lead Sponsor:
Qingdao University
Conditions:
Malignant Glioma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 12 months, with 90 - 95% of patients surviving less than...
Eligibility Criteria
Inclusion
- 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.
- Histologically confirmed diagnosis of 1 of the following malignant gliomas:
- Anaplastic astrocytoma Glioblastoma multiforme Oligodendroglioma Oligoastrocytoma
- Newly diagnosed or recurrent disease
- 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.
- After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
- Supratentorial tumour localisation.
- Karnofsky performance status 60-100%
- Life expectancy ≥ 12 weeks
- Written informed consent of patient and/or legal guardian.
- Must be off of steroid at least two weeks prior to vaccination
- Hematologic and metabolic panel results will be within the parameters of the protocol.
- Negative pregnancy test
- Fertile patients must use effective contraception
- Hepatitis B negative
- Hepatitis C negative
- HIV negative
- Syphilis serology negative
- Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
Exclusion
- Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study,
- Presence of acute infection
- Inability to obtain informed consent because of psychiatric or complicating medical problems.
- Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
- Subjects with organ allografts.
- Contraindication to MRI
- Known history of autoimmune disorder
- Subjects who have an uncontrolled systemic malignancy that is not in remission.
- Pregnancy or breast-feeding.
- Positive for hepatitis B, C, HIV, syphilis
- Patients unwilling to perform a save method of birth control.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01235845
Start Date
January 1 2011
End Date
September 1 2013
Last Update
December 3 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
Qingdao, Shandong, China, 266000