Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

Phase 2

Completed

• Conditions: Glioblastoma
• Interventions: Biological: Dendritic Cell Immunotherapy

• Registration Number: NCT00576537
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2018-10-24
• Status Verified: 2019-04
• Disposition First Submitted QC: 2019-04-30
• Last Update Submitted: 2019-04-30
• Disposition First Posted: 2019-05-03
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dendritic Cell Immunotherapy	Dendritic Cell Immunotherapy	Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.

Primary Outcome Measures

Name	Time	Method
Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells	One year	Cytotoxic T lymphocyte (CTL) precursor frequency

Trial Locations

Locations (1)

Cedars Sinai Medical center; 🇺🇸 Los Angeles, California, United States