NCT00323115

Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Two to six weeks after surgery, patients with newly diagnosed glioblastoma multiforme (GBM) will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide). Between three and seven weeks after completing radiotherapy/chemotherapy, patients will undergo leukapheresis to collect white blood cells. These cells will be grown into dendritic cells, and cultured with tumor cells from the individual patient. Vaccinations will be given every two weeks for a total of three vaccinations. Four weeks after the third vaccination patients will resume chemotherapy for one year or until disease progression.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Dendritic Cell	Vaccine given by cervical lymph node injection 3 times every other week
DRUG	Temozolomide	Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC
PROCEDURE	Radiotherapy	RT is standard of care (SOC) post surgery
BIOLOGICAL	Dendritic Cell Vaccine	Vaccine given cervical lymphnode injection 3 times every other week

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-04-01
• Completion: 2013-07-01
• First posted: 2006-05-09
• Last updated: 2018-10-10
• Results posted: 2012-09-26

Locations

1 site across 1 country: United States