Clinical trial NCT01702792: Derivation of Tumor Specific Hybridomas
Official title: Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Glioblastoma
Keywords: Immunotherapy, cancer vaccine, glioblastoma, hybridoma
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: University of Vermont
First posted: 2012-10-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of hybridoma clones that produce anti-glioma antibodies
timeFrame: 6 months
Secondary outcomes:
measure: Production of Antibodies
timeFrame: 6 months
measure: Toxicity of Vaccine
timeFrame: 6 months
measure: Clone Production Rate
timeFrame: 6 months
measure: Lymph Node Biopsy
timeFrame: 6 months
Other outcomes:
measure: Tumor Binding Characteristics
timeFrame: 6 months
Locations:
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Camilo Fadul, MD
role: PRINCIPAL_INVESTIGATOR
References: