Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors
Completed · Phase 2
Conditions studied: Glioblastoma
In brief
This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.
Key facts
- Study ID
- NCT00576537
- Run by
- Cedars-Sinai Medical Center
- People needed
- 50
- Starts
- 2001-03-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2019-05-03
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
- 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 with atypical malignant brain tumor will be eligible.
- Patients must have a Karnofsky performance score of at least 60%
- patients may be maintained on glucocorticoid therapy at the lowest possible dose.
- Baseline hematologic studies and chemistry profiles must meet the criteria.
- Tumor specimen of adequate size to yield protein concentration in sufficient quantity.
- Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.
- Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.
- Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.
You may not qualify if…
- 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.
- Patients with a known history of an autoimmune disorder.
- Inability to give informed consent.
- Pregnancy.
Where it is running
- Cedars Sinai Medical center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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