Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

NCT00576537 | Completed Phase 2 DMC

• 1 other identifier: 3368
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

New/Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells

  Cytotoxic T lymphocyte (CTL) precursor frequency

  One year

Study Arms (1)

Dendritic Cell Immunotherapy

EXPERIMENTAL

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

Biological: Dendritic Cell Immunotherapy

Interventions

Dendritic Cell Immunotherapy BIOLOGICAL

Patients will receive four vaccines.

Also known as: Dendritic Cell vaccine

Dendritic Cell Immunotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.
• Patients with a known history of an autoimmune disorder.
• Inability to give informed consent.
• Pregnancy.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• 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.

  PMID: 24893855 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• John Yu, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 19, 2007
• Study Start: March 1, 2001
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 3, 2019

Record last verified: 2019-04

Locations

US (1)