A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ® ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Patients With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.
详细描述
OBJECTIVES:
- Determine the safety of NY-ESO-1b peptide vaccine and Montanide® ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.
- Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide® ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks (week 16) and then every 6-12 weeks for 2 years or until disease progression.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, from Stage II-IV at diagnosis, receiving initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
- •High risk feature defined as suboptimal primary debulking (remaining tumor masses with diameter ≥ 1.0 cm) or failure to normalize CA125 during primary therapy by the end of the third cycle or positive second-look surgery.
- •Patients must be in complete clinical remission defined as CA125 < 35 units, negative physical examination and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis may not be considered definite evidence of disease.
- •Expected survival of at least 6 months.
- •Karnofsky performance scale ≥60%.
- •Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
- •Absolute neutrophil count (ANC) ≥1000/mm^3
- •Platelets ≥ 80,000/mm^3
- •Creatinine ≤ 1.5mg/dL
- •Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and total bilirubin all < 2.5 x upper limit of normal (ULN) 7 Age ≥ 18 years.
- •Able and willing to give valid written informed consent.
- •HLA A02 positive.
排除标准
- •Patients were excluded from the study for any of the following reasons:
- •Clinically significant heart disease (NYHA Class III or IV).
- •Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
- •Patients with serious intercurrent illness, requiring hospitalization.
- •Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
- •Patients taking immunosuppressive drugs such as systemic corticosteroids or non-steroidal anti-inflammatory drugs.
- •Known HIV positivity.
- •Other malignancy within 3 years prior to entry into the study, except for treated nonmelanoma skin cancer and cervical carcinoma in situ.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •Lack of availability for immunological and clinical follow-up assessments.
- •Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- •Pregnancy or breastfeeding.
- •Women of childbearing potential: Refusal or inability to use effective means of contraception.
研究组 & 干预措施
NY-ESO-1b peptide with Montanide® ISA-51
Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
干预措施: NY-ESO-1 peptide vaccine (Biological)
结局指标
主要结局
Number of Patients With Dose Limiting Toxicities (DLTs)
时间窗: up to 16 weeks
Toxicities and adverse events defined by National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT defined as: ≥ Grade 2 autoimmune phenomena, asymptomatic bronchospasm or generalized urticaria, or ≥ Grade 3 hematological and non hematological toxicities. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.
次要结局
- Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT(up to 16 weeks)
- Number of Patients Developing NY-ESO-1 Antibodies After Treatment(up to 16 weeks)
- Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis(up to 16 weeks.)
- Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH)(up to 16 weeks)