View Clinical Trial (Medical Research Study)
A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma
| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90095 |
| Conditions: |
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Glioma - Anaplastic Astrocytoma - Anaplastic Astro-oligodendroglioma - Glioblastoma |
| Purpose: |
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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 (interstitial Cajal-like
cell) 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.
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| Study Summary: |
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| Criteria: |
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PATIENT ELIGIBILITY
Inclusion Criteria
1. 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.
2. Patients must have had surgical resection at UCLA (University of California, Los
Angeles), for which a separate informed consent was signed for the collection of
their tumor prior to surgery.
3. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV)
will need to be established.
4. 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.
5. 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
1. Subjects with an active infection.
2. Inability to obtain informed consent because of psychiatric or complicating medical
problems.
3. Unstable or severe intercurrent medical or psychiatric conditions as determined by
the Investigator.
4. Females of child-bearing potential who are pregnant or lactating or who are not using
approved contraception.
5. 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.
6. Subjects with organ allografts.
7. Inability or unwillingness to return for required visits and follow-up exams.
8. Subjects who have an uncontrolled systemic malignancy that is not in remission.
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| NCT ID: |
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NCT01204684 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Los Angeles, California 90095
United States
Emma Young, R.N.
Phone: 310-267-2621
Email: elyoung@mednet.ucla.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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