Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

NCT ID: NCT00576537

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2011-10-31

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dendritic Cell Immunotherapy

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

Group Type: EXPERIMENTAL

Dendritic Cell Immunotherapy

Intervention Type: BIOLOGICAL

Patients will receive four vaccines.

Interventions

Dendritic Cell Immunotherapy

Patients will receive four vaccines.

Intervention Type: BIOLOGICAL

Other Intervention Names

Dendritic Cell vaccine

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John Yu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical center

Los Angeles, California, United States

Countries

United States

References

Jouanneau E, Black KL, Veiga L, Cordner R, Goverdhana S, Zhai Y, Zhang XX, Panwar A, Mardiros A, Wang H, Gragg A, Zandian M, Irvin DK, Wheeler CJ. Intrinsically de-sialylated CD103(+) CD8 T cells mediate beneficial anti-glioma immune responses. Cancer Immunol Immunother. 2014 Sep;63(9):911-24. doi: 10.1007/s00262-014-1559-2. Epub 2014 Jun 4.

Reference Type: DERIVED

PMID: 24893855 (View on PubMed)

Other Identifiers

3368

Identifier Type: -

Identifier Source: org_study_id