TVI-BRAIN-1 Combined With Conformal Radiotherapy and Temozolomide as Treatment for Glioblastoma

What is the Purpose of this Study?

The purpose of this study is to determine the safety and effectiveness of an experimental immunotherapy called TVI-Brain-1 for the treatment of newly diagnosed glioblastomas (a form of brain cancer) when combined with standard-of-care surgery, radiotherapy, and chemotherapy. Study procedures include collection and testing of cancer tissue samples after surgery and chemoradiation therapy (radiation and temozolomide). Patients will be randomly assigned to 1 of 2 groups: the standard-of-care treatment group or the TVI-Brain-1 group. Participants will have a 50% chance of being in the standard treatment alone or in the group receiving standard treatment and the study drug. After surgery, patients assigned to the TVI-Brain-1 group will receive vaccinations to induce an immune response to produce white blood cells. A sample of the patient’s white blood cells (T-cells) will be drawn and used to create an anti-cancer drug that is administered after the completion of radiotherapy and chemotherapy. Temozolomide is approved by the U.S. Food and Drug Administration (FDA) as a treatment for adult glioblastomas.


Eligibility

  • * Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)
  • * Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines
  • * The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department
  • * Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits
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Where can I participate?

Cedars-Sinai Cancer at SOCC : Shannon Cyhan

More about this Clinical Trial

What is the full name of this clinical trial?

TVI-AST-008: Multi-Center Randomized Controlled Phase 2b Clinical Trial To Evaluate the Safety And Efficacy Of Tvi-Brain-1 Combined With Conformal Radiotherapy And Temozolomide Compared To Standard Therapy as a Treatment For Newly Diagnosed O6 -Methylguanine Methyltransferase Negative Grade 4 Astrocytoma

Study Details
Disease Type/Condition

Brain and Nervous System

Principal Investigator

Yu, John

Co-Investigators

Chirag Patil, Jeremy Rudnick, Jethro Hu, Joshua Sasine, Justin Darrah, Ray Chu

Age Group

Adult

Phase

II

IRB Number

STUDY00002637

ClinicalTrials.gov ID

NCT05685004

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org
Study Detail
Disease Type/Condition

Brain and Nervous System

Principal Investigator

Yu, John

Age Group

Adult

Phase

II

IRB Number

TVI-AST-008

ClinicalTrials.gov ID

NCT05685004

Key Eligibility
ClinicalTrials.gov

Contact
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org