CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Autologous Cytomegalovirus-specific Cytotoxic T-lymphocytes +3 morebiological
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/NCT02661282
NCT02661282Phase 2Completed

A Phase I/II Clinical Trial of Autologous CMV-Specific Cytotoxic T Cells for GBM Patients

M.D. Anderson Cancer Center·interventional·Posted Jan 22, 2016·Updated Jun 18, 2023

In Brief

A Phase 2 clinical trial evaluating Autologous Cytomegalovirus-specific Cytotoxic T-lymphocytes, Laboratory Biomarker Analysis, and 2 other interventions for Cytomegalovirus Positive and 5 related conditions. Completed, enrolled 65 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of autologous cytomegalovirus (CMV)-specific cytotoxic T cells when given together with temozolomide and to see how well they work in treating patients with glioblastoma. Autologous CMV-specific cytotoxic T cells may stimulate the immune system to attack specific tumor cells and stop them from growing or kill them. Drugs used in chemotherapy, such as temozolomide, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving autologous CMV-specific cytotoxic T cells with temozolomide may be a better treatment for patients with glioblastoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 22, 2016
Enrollment StartJun 1, 2016
Primary CompletionFeb 23, 2022
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.4 years ago

Interventions

Autologous Cytomegalovirus-specific Cytotoxic T-lymphocytesbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Temozolomidedrug

Given PO

Therapeutic Conventional Surgeryprocedure

Undergo surgery