A Randomized Pilot Trial of Consolidation With an Adjuvant Ovarian Cancer Vaccine Oregovomab (Ovarex ®) With/Without Single-Dose Cyclophosphamide After a Complete Clinical Response to Second-Line Taxane/Platinum-Based Therapy to Determine Immune Response and Time to Progression in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse events as assessed by NCI CTCAE v3.0
研究概览
简要总结
This randomized clinical trial is studying the side effects of oregovomab and to see how well it works with or without cyclophosphamide in treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that responded to second-line chemotherapy. Monoclonal antibodies, such as oregovomab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether oregovomab is more effective when given together with or without cyclophosphamide in treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
详细描述
PRIMARY OBJECTIVES:
I. To characterize the nonspecific humoral immune response, as measured by human anti-murine antibodies (HAMA), in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal adenocarcinoma treated with consolidation therapy comprising adjuvant oregovomab with vs without cyclophosphamide after achieving a complete clinical response to second-line taxane/platinum-based therapy.
II. To compare the magnitude of the immune responses in these patients at approximately 14 weeks after the initial treatment.
III. To determine the frequency and severity of adverse events, as assessed by NCI CTCAE v3.0, in patients treated with these regimens.
SECONDARY OBJECTIVES:
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo delayed-type hypersensitivity (DTH) skin testing with oregovomab and a standard anergy panel (i.e., mumps, Candida, and tetanus toxoid) on day 0 (at baseline) and at week 14. The skin test response is measured 48 hours later. Patients receive cyclophosphamide IV on day 6 and oregovomab IV over 20 minutes on day 9 or 10. Patients then receive oregovomab alone at weeks 6 and 10 and then every 12 weeks for up to 2 years (10 doses) in the absence of disease progression or unacceptable toxicity.
干预措施: Cyclophosphamide (Drug)
Arm I
Patients undergo delayed-type hypersensitivity (DTH) skin testing with oregovomab and a standard anergy panel (i.e., mumps, Candida, and tetanus toxoid) on day 0 (at baseline) and at week 14. The skin test response is measured 48 hours later. Patients receive cyclophosphamide IV on day 6 and oregovomab IV over 20 minutes on day 9 or 10. Patients then receive oregovomab alone at weeks 6 and 10 and then every 12 weeks for up to 2 years (10 doses) in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Procedure)
Arm I
Patients undergo delayed-type hypersensitivity (DTH) skin testing with oregovomab and a standard anergy panel (i.e., mumps, Candida, and tetanus toxoid) on day 0 (at baseline) and at week 14. The skin test response is measured 48 hours later. Patients receive cyclophosphamide IV on day 6 and oregovomab IV over 20 minutes on day 9 or 10. Patients then receive oregovomab alone at weeks 6 and 10 and then every 12 weeks for up to 2 years (10 doses) in the absence of disease progression or unacceptable toxicity.
干预措施: Oregovomab (Biological)
Arm II
Patients undergo DTH skin testing and receive oregovomab as in arm I.
干预措施: Laboratory Biomarker Analysis (Procedure)
Arm II
Patients undergo DTH skin testing and receive oregovomab as in arm I.
干预措施: Oregovomab (Biological)
结局指标
主要结局
Frequency and severity of adverse events as assessed by NCI CTCAE v3.0
时间窗: Up to 30 days after final treatment
Serum human anti-murine antibodies (HAMA) as assessed by enzyme-linked immunosorbent assay (ELISA)
时间窗: At approximately 14 weeks after initial treatment
次要结局
- Frequency and magnitude of patients who have a delayed-type hypersensitivity (DTH) response to oregovomab, tetanus, mumps, and Candida as assessed by DTH skin testing(Baseline to 14 weeks)
- Serum HAMA and anti-idiotype antibodies as assessed by ELISA over the course of treatment(At approximately 14 weeks after initial treatment)
- Duration of time from first response to first recurrence(Up to 5 years)
- Duration of time from second response to second recurrence(Up to 5 years)