Phase I Trial of Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To determine immunologic response
研究概览
简要总结
The purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerprints" are found on many cancer cells, especially from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this study is to see if investigators can help the immune system to recognize that cancer cells are not normal and should be removed.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any histologically documented stage III or IV epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.
- •History of cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment.
- •Patients must be in a first complete clinical remission. Complete clinical remission is defined as serum CA-125 within institutional normal limits, 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 ≤ 1.0cm are often present in the pelvis and will not be considered definite evidence of disease. Eligibility is determined by anatomical imaging only (ie. MRI or CT). Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative.
- •Adequate organ function defined by
- •Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³, grade
- •Platelets greater than or equal to 100,000/mm³.
- •Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade
- •Hepatic function: Bilirubin, SGOT, and alkaline phosphatase less than or equal to 2.5 x ULN
- •Negative stool hemoccult (or negative endoscopic evaluation if positive). External hemorrhoids are a common source of a positive hemoccult and should not exclude patients.
- •TSH not elevated above normal range
- •KPS > or = to 80%.
- •Patients have signed the informed consent document and signed the authorization permitting release of personal health information.
- •Age > 18 years
- •Patients must have recovered from clinically significant side effects from prior chemotherapy
排除标准
- •Pregnant or nursing women
- •Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years, or whose previous cancer treatment contraindicated this protocol therapy are excluded. Non-melanoma skin cancers are an exception and will not exclude any patient.
- •Patients with a history of a seafood allergy.
- •Patients who have previously received a vaccine with any of the antigens in the current trial.
- •Patients with a history of immunodeficiency or autoimmune disease (excluding treated hypothyroidism).
- •Patients with active CNS tumor.
结局指标
主要结局
To determine immunologic response
时间窗: 6 months
immunization with the unimolecular pentavalent carbohydrate-based vaccine bearing Globo-H, GM2, sTn, TF and Tn on a single polypeptide backbone, conjugated to KLH, mixed with the immunological adjuvant QS-21, induces an IgG and IgM antibody response against these individual antigens and tumor cells expressing these antigens.
To determine the maximum tolerated dose over three dose levels.
时间窗: 2 years
Six patients will be accrued to one of three pentavalent vaccine doses (25 mcg, 50 mcg and 100 mcg), and an expansion cohort of six patients will be enrolled at the highest dose level achieved.
To determine the toxicities following immunization with this unimolecular polyvalent vaccine.
时间窗: 2 years
Toxicity will be graded in accordance with the Common Toxicity Criteria Version 4.0 developed by the National Cancer Institute (NCI).
次要结局
- To record the progression free interval(2 years)