Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- number of hybridoma clones that produce anti-glioma antibodies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Tumor Vaccine (Biological)
结局指标
主要结局
number of hybridoma clones that produce anti-glioma antibodies
时间窗: 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.
次要结局
- Lymph Node Biopsy(6 months)
- Production of Antibodies(6 months)
- Toxicity of Vaccine(6 months)
- Clone Production Rate(6 months)