Derivation of Tumor Specific Hybridomas
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas|
- number of hybridoma clones that produce anti-glioma antibodies [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Production of Antibodies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
- Toxicity of Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]• Determining toxicity of vaccine
- Clone Production Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Lymph Node Biopsy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Determine the safety and toxicity issues related to the Lymph Node Biopsy
- Tumor Binding Characteristics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Exploratory objectives will include:
- Determining the rate of tumor binding antibodies from hybridomas derived from circulating B cells.
- Determining the tumor-binding profile of antibodies present in the blood.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Tumor Vaccine
1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity.
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.
Other Name: Autologous Tumor Lysate and Montanide Emulsion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702792
|Contact: Camilo Fadul, MD||(603) 650-6312|
|Contact: Eryn Bagley, CCRCemail@example.com|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756|
|Contact: Camilo Fadul, MD 603-650-4035|
|Contact: Eryn M Bagley 603-650-4035 firstname.lastname@example.org|
|Principal Investigator: Camilo Fadul, MD|
|United States, Vermont|
|University of Vermont - Vermont Cancer Center||Recruiting|
|Burlington, Vermont, United States, 05405|
|Contact: David Krag, MD 802-656-5830|
|Contact: Eileen Caffry 802-656-3447 Eileen.Caffry@uvm.edu|
|Principal Investigator: David Krag, MD|
|Principal Investigator:||Camilo Fadul, MD||Dartmouth-Hitchcock Medical Center|