Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be
done twice and separated by one week. The first vaccination will be performed approximately
2 weeks after surgery.
Approximately one week after the second vaccination one or two vaccine-draining lymph
node(s) will be removed. The lymph node(s) will be identified using SN technology. One or
two lymph node(s) will be removed.
Lymph nodes will be processed for recovery of B cells and formation of hybridomas.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
number of hybridoma clones that produce anti-glioma antibodies
The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.
6 months
No
Camilo Fadul, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
United States: Food and Drug Administration
W12209
NCT01702792
March 2013
August 2013
Name | Location |
---|---|
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University of Vermont - Vermont Cancer Center | Burlington, Vermont 05405 |