Dendritic Cell Vaccine for Patients With Brain Tumors - Full Text View

Sponsor:	University of California, Los Angeles
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01204684

Purpose

The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.

Condition	Intervention	Phase
Glioma Anaplastic Astrocytoma Anaplastic Astro-oligodendroglioma Glioblastoma	Biological: autologous tumor lysate-pulsed DC vaccination	Phase 2

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Study Start Date:

September 2010

Arms	Assigned Interventions
Experimental: Tumor Lysate Antigen +/- Toll-like Receptor Agonists Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination alone. Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 5% imiquimod (TLR7 agonist). Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).	Biological: autologous tumor lysate-pulsed DC vaccination

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

PATIENT ELIGIBILITY

Inclusion Criteria

Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV {anaplastic astrocytoma (AA), anaplastic astro-oligodendroglioma (AO), or glioblastoma (GBM)} will be eligible for this protocol.
Patients must have had surgical resection at UCLA, for which a separate informed consent was signed for the collection of their tumor prior to surgery.
After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
Patients must be 18 years or older and able to read and understand the informed consent document. Patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
Patients must have a Karnofsky performance status (KPS) rating of > 60 prior to initiating treatment. Patients may be enrolled at a KPS of < 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of > 60 by the initiation of treatment.

Exclusion Criteria

Subjects with an active infection.
Inability to obtain informed consent because of psychiatric or complicating medical problems.
Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception.
History of immunodeficiency (e.g., HIV) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy.
Subjects with organ allografts.
Inability or unwillingness to return for required visits and follow-up exams.
Subjects who have an uncontrolled systemic malignancy that is not in remission.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204684

Locations

United States, California
University of Los Angeles, California	Recruiting
Los Angeles, California, United States, 90095
Contact: Emma Young, R.N. 310-267-2621 elyoung@mednet.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

More Information

Additional Information:

UCLA Neurosurgery Brain Tumor Program This link exits the ClinicalTrials.gov site

Publications:

Liau LM, Black KL, Prins RM, Sykes SN, DiPatre PL, Cloughesy TF, Becker DP, Bronstein JM. Treatment of intracranial gliomas with bone marrow-derived dendritic cells pulsed with tumor antigens. J Neurosurg. 1999 Jun;90(6):1115-24.

Liau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, Lin JW, Chute DJ, Mischel PS, Cloughesy TF, Roth MD. Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clin Cancer Res. 2005 Aug 1;11(15):5515-25.

Prins RM, Liau LM. Cellular immunity and immunotherapy of brain tumors. Front Biosci. 2004 Sep 1;9:3124-36. Review.

Prins RM, Cloughesy TF, Liau LM. Cytomegalovirus immunity after vaccination with autologous glioblastoma lysate. N Engl J Med. 2008 Jul 31;359(5):539-41. No abstract available.

Responsible Party:	Robert M. Prins, Ph.D., UCLA Department of Neurosurgery
ClinicalTrials.gov Identifier:	NCT01204684 History of Changes
Other Study ID Numbers:	10-000202
Study First Received:	September 16, 2010
Last Updated:	August 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

dendritic cells
glioma
vaccine
glioma of WHO Grade III or IV

Additional relevant MeSH terms:

Astrocytoma
Glioblastoma
Glioma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 23, 2012