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Personalized Immunotherapy for Glioblastoma
Phase 2 & 3
Recruiting
Led By Michael Salacz, MD
Research Sponsored by TVAX Biomedical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial will study an immunotherapy combining a cancer-patient's own cells and standard treatment to fight glioblastoma. Immune cells will be harvested from the patient, stimulated and expanded, then infused back.
Who is the study for?
This trial is for adults with newly diagnosed MGMT unmethylated glioblastoma who haven't been treated before. They need enough tumor tissue from surgery to make a vaccine, normal kidney and liver function, no current steroid use, good physical function (Karnofsky score > 60), expected to live more than 12 weeks, and specific blood cell counts within the required range. Pregnant individuals or those planning pregnancy within a year are excluded.Check my eligibility
What is being tested?
The study tests TVI-Brain-1 immunotherapy combined with standard care versus standard care alone in treating glioblastoma. It involves creating a personalized vaccine from the patient's cancer cells to boost immune response and infusing expanded T cells back into the patient.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, skin reactions at injection sites; complications from T cell infusion like chills or shortness of breath; and typical chemotherapy/radiotherapy side effects like nausea or hair loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival
Secondary outcome measures
Progression-free survival
Other outcome measures
Immunogenicity
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Other genetic and immunologic parameters
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional TVI-Brain-1 Autologous Vaccine and activated autologous blood-derived t cellsExperimental Treatment4 Interventions
TVI-Brain-1 immunotherapy is integrated with radiation and temozolomide in the test group in the following manner: 1) Subjects undergo surgical resection of their cancer and are tapered off steroids. 2) Subjects receive the first vaccination of TVI-Brain-1 as soon as the laboratory prepared vaccine is available for use (approximately 7 - 14 days following surgery). 3) Subjects receive a second vaccination 7-10 days later. 4) Subjects are leukapheresed to obtain immune T cells for ex vivo-activation. 5) Subjects' T cells are stored frozen until after chemoradiotherapy is completed. 6) Following chemoradiotherapy Subjects are infused with activated effector T cells followed by a 10-day course of low-dose interleukin 2 (IL-2). 7) Subjects then proceed with post therapy surveillance.
Group II: Standard of CareActive Control3 Interventions
Subjects will have standard surgery which will be followed approximately 5 weeks later by combined radiotherapy and chemotherapy consisting of temozolomide 75 mg/m2 dosed once daily beginning on the first day of radiotherapy and continuing until the final day of radiotherapy. Subjects will receive adjuvant temozolomide, and proceed with post therapy surveillance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
TVI-Brain-1
2011
Completed Phase 2
~20
Radiotherapy
2017
Completed Phase 3
~2610
Standard of Care
2017
Completed Phase 4
~4420
Find a Location
Who is running the clinical trial?
FDA Office of Orphan Products DevelopmentFED
70 Previous Clinical Trials
6,218 Total Patients Enrolled
TVAX BiomedicalLead Sponsor
3 Previous Clinical Trials
26 Total Patients Enrolled
3 Trials studying Glioblastoma
26 Patients Enrolled for Glioblastoma
Michael Salacz, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must participants fulfill to join this trial?
"This trial is designed to recruit 96 individuals with glioblastoma. To be eligible, participants must between 18 and 80 years of age."
Answered by AI
Is enrollment in this clinical test restricted to those aged eighteen or above?
"The parameters for this clinical study require participants to be between 18 and 80 years old. There are 35 trials dedicated specifically to minors, while 462 studies target those over 65 years of age."
Answered by AI
Are any additional participants required for this clinical trial?
"Affirmative, the trial is currently soliciting volunteers. Initially posted on September 15th 2023 and last modified on the 25th of that same month, clinicaltrials.gov provides insight into this research endeavor's current status."
Answered by AI
How many people are participating in this experiment?
"Yes, the information on clinicaltrials.gov verifies that this medical trial is actively recruiting patients. It was first posted online on September 15th 2023 and has been amended since then; 96 individuals are being enrolled across a single centre."
Answered by AI
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