Derivation of Tumor Specific Hybridomas
Status: | Completed |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/25/2015 |
Start Date: | January 2014 |
End Date: | August 2015 |
Contact: | Camilo Fadul, MD |
Phone: | (603) 650-6312 |
Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for 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.
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.
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.
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.
We found this trial at
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