Immunotherapy with DCVax-L for Brain Cancer
(GBM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called DCVax-L, a type of immunotherapy, for individuals with glioblastoma (GBM), a form of brain cancer. The goal is to determine if adding DCVax-L to standard treatments—such as surgery, radiation, and Temodar (a chemotherapy drug)—improves outcomes. Two-thirds of participants will receive DCVax-L, while the rest will receive a placebo. Those with newly diagnosed GBM who have undergone surgery and are ready to begin radiation and chemotherapy may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in GBM treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking steroid therapy at least 10 days before a specific procedure called leukapheresis. You must also be willing to avoid other anti-tumor therapies, except for Temodar, while participating in the trial.
Is there any evidence suggesting that DCVax-L is likely to be safe for humans?
Research has shown that DCVax-L, a new treatment being tested for brain cancer, is generally well-tolerated by patients. In studies, some patients lived longer with this treatment. Evidence indicates a 42% reduction in the risk of death for patients treated with DCVax-L compared to those who did not receive it.
The treatment's safety has been tested in a large group of over 300 patients, providing well-documented safety data. While any treatment can have side effects, DCVax-L has shown promising results without major safety concerns in these studies.
These findings suggest that DCVax-L is a relatively safe option for patients considering joining a clinical trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for brain cancer, which often include surgery, radiation, and chemotherapy, DCVax-L offers a novel approach by harnessing the power of the immune system. This treatment is unique because it uses the patient’s own dendritic cells to create a personalized vaccine aimed at targeting and attacking cancer cells. Researchers are excited about DCVax-L because it represents a tailored immunotherapy strategy, potentially leading to more effective and less toxic outcomes compared to traditional therapies. By specifically targeting the tumor cells, DCVax-L could improve survival rates and quality of life for individuals with brain cancer.
What evidence suggests that DCVax-L might be an effective treatment for brain cancer?
Research has shown that DCVax-L, a treatment that aids the immune system in fighting cancer, holds potential for treating glioblastoma, a type of brain cancer. In this trial, some participants will receive DCVax-L, while others will receive a placebo. Studies indicate that patients who received DCVax-L lived longer on average than those who did not. Additionally, the treatment slowed tumor growth. These findings suggest that DCVax-L could complement standard treatments such as surgery, radiation, and Temodar.12367
Who Is on the Research Team?
Linda Liau, M.D.
Principal Investigator
University of California, Los Angeles
Marnix L. Bosch, MBA, PhD
Principal Investigator
Northwest Biotherapeutics
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Resection
Patients undergo surgical resection of the tumor as part of the standard of care
Standard of Care Treatment
Participants receive radiation and Temodar therapy as part of the standard of care
DCVax-L Treatment
Participants receive a series of injections of DCVax-L to activate and boost the immune response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Crossover Arm (optional)
Participants have the option to receive DCVax-L upon documented disease progression
What Are the Treatments Tested in This Trial?
Interventions
- DCVax®-L
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwest Biotherapeutics
Lead Sponsor