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

Phase 1
18 Years
Open (Enrolling)

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of hybridoma clones that produce anti-glioma antibodies

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Camilo Fadul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

August 2013

Related Keywords:

  • Glioblastoma
  • Immunotherapy, cancer vaccine, glioblastoma, hybridoma
  • Glioblastoma



Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Vermont - Vermont Cancer Center Burlington, Vermont  05405