NCT01081223

Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: TVAX Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.

Detailed description

TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated twice with those cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. Finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.

Conditions

• Glioma
• High Grade Astrocytoma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
BIOLOGICAL	Cancer vaccine plus immune adjuvant	Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-03-05
• Last updated: 2023-06-01
• Results posted: 2023-06-01

Locations

1 site across 1 country: United States