Derivation of Tumor Specific Hybridomas

Phase 1

Terminated

• Conditions: Glioblastoma
• Interventions: Biological: Tumor Vaccine

• Registration Number: NCT01702792
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-08
• Study Start: 2014-01
• Primary Completion: 2015-05-06
• Study Completion: 2015-05-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery
• Age > 18 years
• KPS Score of greater than or equal to 70
• Adequate bone marrow as evidenced by:

Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL

• Adequate renal function as evidenced by serum creatinine < 2.0
• Patients must be able to read, understand and provide informed consent to participate in the trial.
• Patients of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following vaccination (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria

A patient may not be enrolled in the trial if any of the following criteria are met:

• Patients receiving dexamethasone > 8 mg/day during the week before vaccination.
• Patients who are pregnant or lactating
• Patients with active second malignancy.
• Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor Vaccine	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.

Primary Outcome Measures

Name	Time	Method
number of hybridoma clones that produce anti-glioma antibodies	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Lymph Node Biopsy	6 months	Determine the safety and toxicity issues related to the Lymph Node Biopsy
Production of Antibodies	6 months	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	6 months	• Determining toxicity of vaccine
Clone Production Rate	6 months	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.