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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 until death
Awards & highlights

GBM Trial Summary

This trial is testing a new therapy, DCVax-L, for patients with newly diagnosed Glioblastoma (GBM) who are scheduled for surgery. The patients will receive the standard of care, including radiation and Temodar therapy, and then will be randomly assigned to also receive either DCVax-L or a placebo. All patients will have the option to receive DCVax-L after their disease progresses.

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.Check my eligibility
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.See study design
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.

GBM Trial 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.

GBM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma.
Secondary outcome measures
The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM.

GBM Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: treatment cohortActive Control1 Intervention
Group II: Placebo ChohortPlacebo Group1 Intervention
Autologous PBMC

Find a Location

Who is running the clinical trial?

Northwest BiotherapeuticsLead Sponsor
7 Previous Clinical Trials
120 Total Patients Enrolled
2 Trials studying Glioblastoma
Linda Liau, M.D.Principal InvestigatorUniversity of California, Los Angeles
Marnix L. Bosch, MBA, PhDStudy DirectorNorthwest Biotherapeutics

Media Library

DCVax®-L (Dendritic cell immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00045968 — Phase 3
Glioblastoma Research Study Groups: treatment cohort, Placebo Chohort
Glioblastoma Clinical Trial 2023: DCVax®-L Highlights & Side Effects. Trial Name: NCT00045968 — Phase 3
DCVax®-L (Dendritic cell immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00045968 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals below the age of 50 years old enroll in this research project?

"To be eligible for this study, patients must meet the age requirement of being between 18 and 70 years old."

Answered by AI

Could I join this experiment if I meet the requirements?

"This clinical trial is recruiting 348 participants with glioblastoma between the ages of 18 and 70. Most importantly, patients should meet the following criteria: Patients may have received steroid therapy as part of their primary treatment. Steroid treatment must be stopped at least 10 days prior to leukapheresis., Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide essentially according to the schedule of the Stupp Protocol (Stupp et al. N Engl J Med 352: 987-96, 2005) while being treated with DCVax-L. DCV"

Answered by AI

At how many different locations are patients enrolling in this clinical trial?

"Recruitment for this clinical trial ended at some point prior to May 12th, 2022. The study was first posted on December 1st, 2006. For individuals looking for other trials, 1084 studies involving glioblastoma are actively recruiting patients while 3 more trials pertaining to the treatment cohort are also searching for participants."

Answered by AI

Are there similar ongoing or previous research projects with a comparable group of test subjects?

"Currently, there are three clinical trials underway for the treatment cohort. One of those is in Phase 3. The majority of research sites for this treatment are located in Camden, New jersey; however, 91 different locations across the world are running studies related to this treatment option."

Answered by AI

Has this proposed course of treatment been cleared by the FDA?

"Power's analysts have determined that the safety of this treatment falls in the third tier, as it is a Phase 3 trial. There is some efficacy data, but more importantly multiple rounds of clinical trials support its safety record."

Answered by AI

Where are the patients being seen for this experiment?

"As of right now, this trial is enrolling patients from 74 different sites. Some of these locations are in New york, Gainesville and Chicago. To try and make the process more convenient for participants, it is best to select a location that is close to where you live."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Wake Forest Baptist Medical Center
~19 spots leftby Mar 2025