This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.
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.
Time frame: 6 months
Production of Antibodies
Secondary outcomes will include: Determining how many hybridoma clones produce glioblastoma-specific antibodies. The initial secondary endpoint will include the counting of the number of hybridoma clones sourced from the dermal vaccine draining lymph nodes that generate specific glioma antibodies.
Time frame: 6 months
Toxicity of Vaccine
• Determining toxicity of vaccine
Time frame: 6 months
Clone Production Rate
Determining whether B cells sourced from the vaccine nodes produce more anti-tumor antibody hybridomas than the non-vaccine node. The rate of producing these clones will be compared according to the source of the B cells. Thus, B cells recovered from vaccine related nodes will be compared to B cells recovered from the non-vaccine node.
Time frame: 6 months
Lymph Node Biopsy
Determine the safety and toxicity issues related to the Lymph Node Biopsy
Time frame: 6 months
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