CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
TVI-Brain-1biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01290692
NCT01290692Phase 2Completed
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Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

TVAX Biomedical·interventional·Posted Feb 7, 2011·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating TVI-Brain-1 for Grade IV Glioma and 2 related conditions. Completed, enrolled 14 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrade IV Glioma, Grade IV Astrocytoma, Glioblastoma Multiforme
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2011
Enrollment StartJun 1, 2011
Primary CompletionDec 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.4 years ago

Interventions

TVI-Brain-1biological

Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.