A Phase 2, Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Cetuximab and Lomustine (CCNU) in Adults with Recurrent High-Grade Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
Glioblastoma (GBM) is the most common and aggressive brain cancer in adults. Even after surgery, radiation, and chemotherapy, the tumor almost always returns. When GBM recurs, treatment options are very limited and usually provide only short-term benefit. There is a strong need for new and more effective therapies for patients with recurrent GBM. Many GBM tumors show changes in a protein called EGFR, which helps cancer cells grow. Cetuximab is a medicine that targets EGFR and blocks its activity. It is already used for other cancers, and research suggests it may help slow tumor growth in GBM, especially in tumors with EGFR amplification or EGFRvIII mutation. Lomustine (also known as CCNU) is an oral chemotherapy commonly used for recurrent GBM. Although it offers modest benefit when used alone, it is known to work better in combination with other treatments. The CLARITY-GBM study is a Phase 2 clinical trial that will test whether giving cetuximab along with lomustine can better control tumor growth in adults whose GBM has returned after standard treatment. About 25 participants will take part across multiple hospitals. All participants will receive cetuximab through a vein every two weeks and lomustine as a single oral dose every six weeks. The main goal is to find out how many patients remain alive and without tumor progression six months after starting treatment. The study also aims to evaluate overall survival, MRI-based tumor response, quality of life, side effects, and steroid use. Blood and tumor samples may also be collected to explore biomarkers that could help predict treatment response. This research aims to determine whether the combination of cetuximab and lomustine can offer a promising new treatment option for people with recurrent glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age more than equal to18 years and histologically confirmed WHO grade 4 Glioblastoma or Gliosarcoma.
- •2.Radiographic first or second recurrence after prior standard radiotherapy with concurrent or adjuvant temozolomide.
- •3.Measurable enhancing disease by MRI per RANO within 14 days prior to randomization and stable or decreasing corticosteroid dose for more than equal to 5 days before baseline MRI.
- •4.ECOG performance status 0 to
- •5.Adequate organ function ANC more than equal to 1.5×109 per L platelets more than equal to 100×109 per L hemoglobin more than equal to 9 g per dL total bilirubin less than equal to 1.5×ULN AST or ALT less than equal to 2.5×ULN creatinine clearance more than equal to 50 mL per min (Cockcroft–Gault).
- •6.Life expectancy more than equal to 12 weeks.
- •7.MGMT promoter methylation and EGFR status (amplification or EGFR vIII) locally assessed if available 8.Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during treatment and for 6 months after last dose.
- •9.Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during treatment and for 6 months after last dose and men must agree to use contraception.
- •10.Written informed consent obtained prior to any study procedures.
排除标准
- •1.More than two prior systemic anticancer regimens for GBM at recurrence.
- •2.Prior EGFR targeted therapy for GBM e.g., cetuximab, panitumumab, EGFR TKIs at recurrence.
- •3.Known IDH mutant astrocytoma grade 4 without histologic features of GBM (central confirmation not required).
- •4.Uncontrolled intercurrent illness including active infection requiring systemic therapy significant pulmonary disease predisposing to infusion reactions; uncontrolled cardiac disease (NYHA class III/IV).
- •5.Known severe hypersensitivity to cetuximab, murine proteins, or components of the formulation history of severe infusion reaction to chimeric antibodies.
- •6.Pregnancy or breastfeeding.
- •7.Inability to undergo MRI with contrast or to comply with study procedures.
研究者
Dr Vijay Patil
SunAct Cancer Institute Pvt Ltd