What side effects are associated with this type of intervention?

Common treatments for brain tumors, including those similar to dendritic cell vaccines, can have various side effects. Immunotherapy, which aims to stimulate the immune system, can lead to immune-related adverse events such as inflammation, fatigue, fever, and injection site reactions. Chemotherapy and radiation therapy, often used in conjunction with immunotherapy, can cause neurocognitive decline, fatigue, nausea, and an increased risk of infections. These side effects vary depending on the specific treatment regimen and the patient's overall health.

What prior FDA approvals exist?

FDA approvals for brain tumor treatments that involve antigen presentation and immune system stimulation are limited. However, investigational therapies such as dendritic cell vaccines, which aim to stimulate the immune system to recognize and destroy tumor cells, are being actively studied. Other immunotherapies, including immune checkpoint inhibitors like pembrolizumab, have shown promise in treating various cancers, including glioblastoma, by enhancing the body's immune response against tumor cells. These approaches represent a growing area of research and potential future FDA approvals.

What other types of research exist?

Promising novel alternatives to Dendritic Cell Vaccine for brain tumor patients include: 1) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which have shown efficacy in treating high-grade gliomas. 2) CAR-T cell therapy, which is being explored for its potential to target specific tumor antigens. 3) Novel targeted therapies like Depatux-M (depatuxizumab mafodotin) for EGFR-amplified glioblastoma. These treatments are at various stages of clinical trials and have shown potential in improving outcomes for brain tumor patients.

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Cancer Vaccine

Dendritic Cell Vaccine for Brain Cancer

Phase 2

Waitlist Available

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be 18 years or older and able to read and understand the informed consent document

Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV (anaplastic astrocytoma, anaplastic astro-oligodendroglioma, or glioblastoma) eligible

Must not have

Inability or unwillingness to return for required visits and follow-up exams

Subjects with organ allografts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a vaccine made from a patient's own immune cells and tumor pieces to help their body fight a serious brain tumor called malignant glioma. The goal is to see which combination of vaccine components works best. The vaccine trains the immune system to recognize and attack the tumor. This type of treatment has shown promise in treating malignant gliomas by enhancing the immune response and improving patient outcomes.

Who is the study for?

This trial is for adults with malignant glioma (brain tumors) who've had surgery at UCLA. They must have a certain level of physical ability (KPS > 60), be able to consent, and not have infections, severe medical conditions, organ transplants, other active cancers, or immune/autoimmune diseases. Women must not be pregnant and should use contraception.

What is being tested?

The study tests different immunotherapy vaccines on brain tumor patients. It uses the patient's own dendritic cells combined with their tumor tissue to stimulate the immune system against the tumor. Some treatments include adjuvants like imiquimod or poly ICLC to boost effectiveness.

What are the potential side effects?

While previous studies suggest safety, potential side effects may include reactions at injection sites, flu-like symptoms due to immune response activation, and possible worsening of autoimmune conditions if present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and can understand the consent form.

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My brain tumor is classified as Grade III or IV glioma.

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I had surgery at UCLA and agreed to donate my tumor for research.

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My surgery confirmed I have a high-grade malignant brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot or do not want to come back for needed follow-ups.

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I have received an organ transplant.

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I have a history of immune system problems that could worsen with immunotherapy.

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I currently have an active infection.

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I am not pregnant, breastfeeding, and I use approved birth control methods.

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I have cancer that is not under control and not in remission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.Experimental Treatment1 Intervention

Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).

Group II: Tumor lysate-pulsed DC vaccination+0.2% resiquimod.Experimental Treatment1 Intervention

Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.

Group III: Tumor Lysate-pulsed DC vaccinationExperimental Treatment1 Intervention

Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

autologous tumor lysate-pulsed DC vaccination

2010

Completed Phase 2

~30

Tumor lysate-pulsed DC vaccination+0.2% resiquimod

2010

Completed Phase 2

~30

Tumor-lysate pulsed DC vaccination +adjuvant polyICLC

2010

Completed Phase 2

~30

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for brain tumors include surgery, radiation therapy, chemotherapy, and immunotherapy. Dendritic cell vaccines, a form of immunotherapy, work by isolating dendritic cells from the patient's blood and pulsing them with tumor-cell lysate from the patient's tumor. This process aims to stimulate the immune system to recognize and attack the tumor cells. The dendritic cells present tumor antigens to T-cells, teaching the immune system to identify the tumor as foreign. This mechanism is crucial for brain tumor patients as it offers a targeted approach to eliminate cancer cells while potentially reducing the side effects associated with traditional treatments.

Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.Not Yet Another Negative Trial-ReACTing on Recent Glioblastoma Trials.Dendritic cell-based immunotherapy for glioma: multiple regimens and implications in clinical trials.