AzTrials
AzTrials

GliomaPhase 2NCT01204684

Dendritic Cell Vaccine for Patients With Brain Tumors

A Phase 2 study testing autologous tumor lysate-pulsed DC vaccination, Tumor lysate-pulsed DC vaccination+0.2% resiquimod and Tumor-lysate pulsed DC vaccination +adjuvant polyICLC in people with Glioma and Anaplastic Astrocytoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
autologous tumor lysate-pulsed DC vaccination, Tumor lysate-pulsed DC vaccination+0.2% resiquimod and Tumor-lysate pulsed DC vaccination +adjuvant polyICLC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
8 Oct 2010to 21 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Los Angeles, California

    Los Angeles, California, 90095

Other trials in United States

About this study

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

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.

Being tested
autologous tumor lysate-pulsed DC vaccination, Tumor lysate-pulsed DC vaccination+0.2% resiquimod, Tumor-lysate pulsed DC vaccination +adjuvant polyICLC
Keywords
dendritic cells, glioma, vaccine, glioma of WHO Grade III or IV
Medical subject headings
Glioma, Astrocytoma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous tumor lysate-pulsed DC vaccinationBiological

  • Tumor lysate-pulsed DC vaccination+0.2% resiquimodBiological

  • Tumor-lysate pulsed DC vaccination +adjuvant polyICLCBiological

Study groups in NCT01204684
Study groupRoleWhat they receive
Tumor Lysate-pulsed DC vaccinationExperimentalCohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.
Receives: Biological: autologous tumor lysate-pulsed DC vaccination
Tumor lysate-pulsed DC vaccination+0.2% resiquimod.ExperimentalCohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.
Receives: Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod
Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.ExperimentalCohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).
Receives: Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Most effective combination of DC vaccine components

    Measured: 6 weeks

Secondary outcomes (1)

  1. Time to tumor progression and overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)
  2. Study start8 Oct 2010
  3. Primary completion21 Aug 2024
  4. Study completion21 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204684
Sponsor's protocol ID
10-000202
Status last verified
Aug 2024
First submitted
16 Sep 2010
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
Yes

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. doi: 10.3171/jns.1999.90.6.1115.

    PubMed 10350260

  • 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. doi: 10.1158/1078-0432.CCR-05-0464.

    PubMed 16061868

  • Prins RM, Liau LM. Cellular immunity and immunotherapy of brain tumors. Front Biosci. 2004 Sep 1;9:3124-36. doi: 10.2741/1465.

    PubMed 15353342

  • 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. doi: 10.1056/NEJMc0804818. No abstract available.

    PubMed 18669440

  • Everson RG, Hugo W, Sun L, Antonios J, Lee A, Ding L, Bu M, Khattab S, Chavez C, Billingslea-Yoon E, Salazar A, Ellingson BM, Cloughesy TF, Liau LM, Prins RM. TLR agonists polarize interferon responses in conjunction with dendritic cell vaccination in malignant glioma: a randomized phase II Trial. Nat Commun. 2024 May 8;15(1):3882. doi: 10.1038/s41467-024-48073-y.

    PubMed 38719809

  • Everson RG, Hugo W, Sun L, Antonios J, Lee A, Ding L, Bu M, Khattab S, Chavez C, Billingslea-Yoon E, Salazar A, Ellingson BM, Cloughesy TF, Liau LM, Prins RM. Dendritic Cell Vaccination in Conjunction with a TLR Agonist Polarizes Interferon Immune Responses in Malignant Glioma Patients. Res Sq [Preprint]. 2023 Sep 12:rs.3.rs-3287211. doi: 10.21203/rs.3.rs-3287211/v1.

    PubMed 37790490

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing autologous tumor lysate-pulsed DC vaccination, Tumor lysate-pulsed DC vaccination+0.2% resiquimod and Tumor-lysate pulsed DC vaccination +adjuvant polyICLC in people with Glioma and Anaplastic Astrocytoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Most effective combination of DC vaccine components (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204684, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

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