What is the mechanism of action of this treatment?

DCVax-L is a dendritic cell vaccine designed to stimulate the immune system to target and destroy Glioblastoma cells. This treatment involves extracting dendritic cells from the patient, exposing them to tumor antigens, and reintroducing them to elicit a targeted immune response. This mechanism is crucial for Glioblastoma patients as it offers a personalized approach that leverages the body's own immune system, potentially leading to more effective and sustained responses compared to traditional treatments such as surgery, radiation, and chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, including surgery, radiation, and chemotherapy, often result in side effects such as fatigue, nausea, hair loss, and increased risk of infections. Immunotherapies like DCVax-L, which stimulate the immune system to attack tumor cells, can also cause immune-related side effects such as inflammation, fever, chills, and fatigue. Additionally, patients may experience headaches, skin reactions at the injection site, and flu-like symptoms. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, an oral chemotherapy drug, and bevacizumab, an anti-VEGF monoclonal antibody. While DCVax-L is a dendritic cell vaccine designed to stimulate the immune system to target tumor cells, similar immunotherapy approaches include the use of checkpoint inhibitors like nivolumab and pembrolizumab, which have shown promise in treating various cancers by enhancing the body's immune response against tumor cells. These treatments represent a shift towards leveraging the immune system to combat Glioblastoma.

What other types of research exist?

Promising novel alternatives to DCVax-L for Glioblastoma patients include: 1) CAR T-cell therapy, which involves modifying a patient's T-cells to target tumor-specific antigens; 2) Oncolytic virus therapy, such as Toca 511, which uses viruses to selectively infect and kill tumor cells; 3) Checkpoint inhibitors like nivolumab and pembrolizumab, which help the immune system recognize and attack cancer cells; 4) Tumor Treating Fields (TTF), a non-invasive treatment that uses electric fields to disrupt cancer cell division; and 5) Personalized neoantigen vaccines, which are tailored to the unique mutations in a patient's tumor.

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Dendritic cell immunotherapy

Immunotherapy with DCVax-L for Brain Cancer (GBM Trial)

Phase 3

Waitlist Available

Led By Linda Liau, M.D.

Research Sponsored by Northwest Biotherapeutics

Eligibility Criteria Checklist

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

Must have

Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy

Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial tests DCVax-L, a treatment using a patient's own immune cells, in patients with newly diagnosed GBM undergoing surgery. It aims to train their immune system to better attack brain cancer cells. This treatment is being tested in several clinical trials, with safety and feasibility proven and promising clinical results reported.

Who is the study for?

This trial is for adults aged 18-70 with newly diagnosed, unilateral GBM brain cancer who've had surgery aiming to remove most of the tumor. They should have completed radiation and Temodar chemotherapy, not be on steroids for at least 10 days before leukapheresis, and must avoid other cytotoxic therapies except temozolomide. Participants need proper liver and kidney function, a KPS rating of ≥70, enough tumor material from surgery for vaccine creation, and a life expectancy over 8 weeks.

What is being tested?

The study tests DCVax-L immunotherapy's effectiveness in patients with new GBM after surgical removal of their tumors. Two-thirds will receive DCVax-L plus standard care (radiation & Temodar), while one-third gets a placebo. If the disease worsens, all can get DCVax-L in a crossover arm.

What are the potential side effects?

While specific side effects are not listed here, dendritic cell immunotherapy like DCVax-L may cause immune-related reactions such as flu-like symptoms, injection site reactions or potentially more serious autoimmune responses.

Eligibility Criteria

Inclusion Criteria

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

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My initial treatment was surgery to remove as much of the tumor as possible, followed by radiation and Temodar chemotherapy.

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My tumor sample from surgery is enough for the protein test.

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I have enough DCVax-L available for treatment after it was made.

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I have been diagnosed with Grade IV brain cancer in one side of my brain.

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I am mostly able to take care of myself.

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I am between 18 and 70 years old and can legally consent.

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My cancer did not worsen after finishing radiation therapy.

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: treatment cohortActive Control1 Intervention

Group II: Placebo ChohortPlacebo Group1 Intervention

Autologous PBMC

0 / 7Eligibility 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

DCVax-L is a dendritic cell vaccine designed to stimulate the immune system to target and destroy Glioblastoma cells. This treatment involves extracting dendritic cells from the patient, exposing them to tumor antigens, and reintroducing them to elicit a targeted immune response. This mechanism is crucial for Glioblastoma patients as it offers a personalized approach that leverages the body's own immune system, potentially leading to more effective and sustained responses compared to traditional treatments such as surgery, radiation, and chemotherapy.