NCT01702792

Derivation of Tumor Specific Hybridomas

Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	Tumor Vaccine	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-05-06
• Completion: 2015-05-06
• First posted: 2012-10-08
• Last updated: 2018-04-04