Open-label Phase II Trial of the Safety and Efficacy of V-Boost in Patients With Refractory Glioblastoma Multiforme (GBM)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effect on tumor size
研究概览
简要总结
The Phase II study to determine the safety and efficacy of V-Boost in treating a type of brain cancer called Glioblastoma Multiforme (GBM). V-Boost is an immunotherapy in which the patient's immune system will be modulated to eliminate tumor cells. V-Boost is made as an oral tablet which contains specially formulated hydrolyzed GBM antigens along with alloantigens. Patients are either newly diagnosed or with recurrent form of GBM who may have been subjected to surgery and/or chemo- or radiation therapy that ended up unsuccessful. The goal is to eradicate GBM tumor cells through daily oral administration of one pill of V-Boost immunotherapeutic vaccine, which so far has not shown any adverse reaction.
详细描述
The proposed Phase II trial is an-open label study of the safety and efficacy of V-Boost in newly diagnosed or treatment-refractory patients with glioblastoma multiforme (GBM) following unsuccesfull resection and/or chemoradiation. The Phase I clinical tria,l carried out in a small, open-label study, demonstrated safety and promising efficacy. The purpose of this study is to gain additional information from a larger clinical trial aimed to recruit at least 20 patients with GBM. Patients may be newly diagnosed with GBM or are those who have been subjected to resection and/or chemotherapy or radiation, but without success. Patients need to have imaging records and health assessment prior to study enrollment. Those on chemotherapy or radiation can be in washout period or may receive immunotherapy concurrently. Patients will be administered daily dose of V-Boost oral tablet for at least one month and additional dosing can be envisaged depending on outcome of first month. The primary objective is to evaluate the effect on tumor size and progression free survival (PFS) in comparison to patients on standard of care.
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
盲法说明
This is open label study, no masking is required
入排标准
- 年龄范围
- 5 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of GBM
- •≥ 5 years of age
- •Consent from parents or legal guardian if under-aged
排除标准
- •Severe pulmonary, cardiac or other systemic disease
- •Presence of an acute infection requiring active treatment with antibiotics/antivirals
- •Receiving corticosteroids (e.g., dexamethasone) during study duration
研究组 & 干预措施
V-Boost recipients
In this open label study all eligible participants will receive daily tablet of V-Boost
干预措施: V-Boost (Biological)
结局指标
主要结局
Effect on tumor size
时间窗: 3 months
Imaging of brain at 3-month time post-therapy and comparison to baseline records
次要结局
- Effect on progression-free survival(3 months)