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Immunotherapy with DCVax-L for Brain Cancer (GBM Trial)
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.
GBM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGBM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.GBM Trial Design
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- My initial treatment involved surgery to remove most of the tumor, followed by radiation and Temodar chemotherapy.I stopped taking steroids at least 10 days before my leukapheresis.My tumor material is enough for the vaccine production.I had surgery to remove most of my tumor, followed by radiation and Temodar chemotherapy.I agree to follow the specific treatment plan with DCVax-L and temozolomide as outlined.My initial treatment was surgery to remove as much of the tumor as possible, followed by radiation and Temodar chemotherapy.I agree not to receive certain cancer treatments except for temozolomide as per the Stupp Protocol while on DCVax-L.I stopped taking steroids at least 10 days before my leukapheresis.My tumor sample from surgery is enough for the protein test.I have enough DCVax-L available for treatment after it was made.I am mostly able to take care of myself.I have been diagnosed with Grade IV brain cancer in one side of my brain.I stopped taking steroids at least 10 days before my leukapheresis.My tumor sample from surgery is enough for the protein test.My bone marrow is working well.I completed all required tests and criteria within four weeks after my cancer treatment.I have been diagnosed with Grade IV brain cancer (GBM) for the first time.My cancer did not worsen after radiation therapy.My liver and kidney functions are within normal limits.My bone marrow, liver, and kidneys are working well.I am between 18 and 70 years old and can legally consent.My cancer did not worsen after finishing radiation therapy.
- Group 1: treatment cohort
- Group 2: Placebo Chohort
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
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