Dendritic Cell Vaccine for Patients With Brain Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01204684 |
Recruitment Status :
Active, not recruiting
First Posted : September 17, 2010
Last Update Posted : July 19, 2022
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Condition or disease | Intervention/treatment | Phase |
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Glioma Anaplastic Astrocytoma Anaplastic Astro-oligodendroglioma Glioblastoma | Biological: autologous tumor lysate-pulsed DC vaccination Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
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 |
Actual Study Start Date : | October 8, 2010 |
Estimated Primary Completion Date : | January 31, 2024 |
Estimated Study Completion Date : | January 31, 2025 |

Arm | Intervention/treatment |
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Experimental: Tumor Lysate-pulsed DC vaccination
Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.
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Biological: autologous tumor lysate-pulsed DC vaccination |
Experimental: Tumor lysate-pulsed DC vaccination+0.2% resiquimod.
Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.
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Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod |
Experimental: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.
Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).
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Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC |
- Most effective combination of DC vaccine components [ Time Frame: 6 weeks ]
- Time to tumor progression and overall survival [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 (University of California, Los Angeles), 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204684
United States, California | |
University of Los Angeles, California | |
Los Angeles, California, United States, 90095 |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01204684 |
Other Study ID Numbers: |
10-000202 |
First Posted: | September 17, 2010 Key Record Dates |
Last Update Posted: | July 19, 2022 |
Last Verified: | July 2022 |
dendritic cells glioma vaccine glioma of WHO Grade III or IV |
Glioblastoma Glioma Astrocytoma Oligodendroglioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Poly ICLC Interferon Inducers Immunologic Factors Physiological Effects of Drugs |