Randomized Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- 1-year Progression-free Survival
研究概览
简要总结
Study of galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.
详细描述
The doctors are testing galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth. Mesothelioma tumors generally have high levels of WT1.This study was originally designed to have two treatment groups. One group received non-specific immunotherapy with medications called Montanide and Sargramostim (Granulocyte Macrophage Colony Stimulating Factor, GM-CSF). Enrollment to this group has stopped The other group, which continues receives more specific immunotherapy with galinpepimut-S plus Montanide and GM-CSF. Both Montanide and GM-CSF are commonly given along with vaccines because they have a general effect in boosting the immune response. Some researchers believe that this general increase in the immune system may have some effect in treating cancer. Some studies using GM-CSF with melanoma vaccines have suggested that it could lessen the effects of the vaccine. The addition of the WT1 proteins makes this therapy more directed to mesothelioma. The combination of galinpepimut-S with Montanide and GM-CSF has been tested in a prior trial including 9 patients with advanced mesothelioma. In that trial, the vaccine was safe and caused an immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution.
- •Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
- •Completion of multimodality therapy. This must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy.
- •4-12 weeks since completion of combined modality therapy.
- •Age > or = to 18 years
- •Karnofsky performance status > or = to 70%
- •Hematologic parameters: Absolute neutrophil count > or = to 1000/mcL, Platelets > or = to 50K/mcL.
- •Biochemical parameters: Total bilirubin < or = to 2.0 mg/dl, AST and ALT < or = to 2.5 x upper limits of normal, Creatinine < or = to 2.0 mg/dl.
排除标准
- •Pregnant or lactating women.
- •Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
- •Patients with a serious unstable medical illness or another active cancer.
- •Patients taking systemic corticosteroids.
- •Patients with an immunodeficiency syndrome.
研究组 & 干预措施
Galinpepimut-S + Montanide + GM-CSF
Galinpepimut-S emulsified with Montanide adjuvant (1:1 ratio) 1 mL and GM-CSF 70 mcg
干预措施: Galinpepimut-S + Montanide + GM-CSF (Biological)
Montanide + GM-CSF
Montanide adjuvant 1 mL and GM-CSF 70 mcg
干预措施: Montanide + GM-CSF (Biological)
结局指标
主要结局
1-year Progression-free Survival
时间窗: 1 year
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Progression-free Survival
时间窗: Up to 5 years and 11 months
Median progression free survival (PFS) is where PFS are assessed from the time of randomization to first evidence of disease recurrence or death of any cause.
次要结局
- Overall Survival(Uo to 5 years and 11 months)
- Immune Response(12 weeks)