CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Autologous Dendritic Cell +3 morebiological
Likely dose
Autologous dendritic cell vaccine given by cervical lymph node injection 3 times every other weekAI-extracted
Key inclusion· 8
  • Histologically proven glioblastoma multiforme with central pathology review
  • Tumor specimen obtained at surgery adequate for vaccination
  • Age 18 years or older
  • Karnofsky Performance Status 60% or greater
Key exclusion· 6
  • Invasive malignancies in the past 5 years
  • History of rheumatologic or autoimmune disease
  • Active autoimmune disease
  • Pregnancy or unwillingness to use acceptable birth control

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

Search/NCT00323115
NCT00323115Phase 2Completed

A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

Dartmouth-Hitchcock Medical Center·interventional·Posted May 9, 2006·Updated Oct 10, 2018

In Brief

A Phase 2 clinical trial evaluating Autologous Dendritic Cell, Temozolomide, and 2 other interventions for Glioblastoma Multiforme. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will be administered after three vaccinations for one year or until progression of disease.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2008
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.1 years ago

Interventions

Autologous Dendritic Cellbiological

Vaccine given by cervical lymph node injection 3 times every other week

Temozolomidedrug

Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC

Radiotherapyprocedure

RT is standard of care (SOC) post surgery

Dendritic Cell Vaccinebiological

Vaccine given cervical lymphnode injection 3 times every other week