Glioblastoma
Conditions
Keywords
New/Recurrent Glioblastoma
Brief summary
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.
Detailed description
To become eligible for therapy the following criteria must be fulfilled: * No age or gender limit * Patients with atypical malignant brain tumors. * Must have a Karnofsky performance of at least 60% * Hematologic studies and chemistry profiles will be within the parameters of the protocol * Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine. * Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.
Interventions
BIOLOGICALDendritic Cell Immunotherapy
Patients will receive four vaccines.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells | One year | Cytotoxic T lymphocyte (CTL) precursor frequency |
Countries
United States
Outcome results
None listed