Status:
COMPLETED
Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Malignant Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 24 months. The current standard treatment of surgical re...
Detailed Description
Dendritic cells are a small group of cells contained in everyone's white blood cell population. These cells are responsible for letting the immune system know that something foreign is in the body. De...
Eligibility Criteria
Inclusion
- Patients must have a histopathological diagnosis of malignant glioma.
- Patients 18 years of age or older.
- Patients must have undergone maximal surgical resection of malignant glioma
- Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
- Patients must have a Karnofsky performance score of at least 60%.
- Patients must be off steroids for at least two weeks prior to vaccination.
- Baseline hematologic and complete metabolic panel within one week of initiating therapy must fall within normal ranges
- Patient must be capable of signing IRB approved Research Consent and Release of Medical Records form.
Exclusion
- Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
- The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
- Contraindication to MRI procedure unless otherwise determined by PI.
- Patients with a known history of an autoimmune disorder.
- Pregnancy.
- Patients positive for hepatitis B, hepatitis C, HIV I/II, syphilis, HTLV I/II, HCV.
- Patients with allergy to Gentamicin.
- Patient inability to participate as determined by PI discretion.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01792505
Start Date
October 1 2009
End Date
October 1 2016
Last Update
April 21 2017
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048