Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

Cedars-Sinai Medical Center

Status and phase

Completed

Phase 2

Conditions

Glioblastoma

Treatments

Biological: Dendritic Cell Immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00576537

3368

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Volunteers

No Healthy Volunteers

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.