A Phase II Study of Concurrent IGFBP-2 Vaccination and Neoadjuvant Chemotherapy to Increase the Rate of Pathologic Complete Response at the Time of Cytoreductive Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Rate of Pathologic Complete Response (CR)
研究概览
简要总结
This phase II trial studies how well pUMVC3-IGFBP2 plasmid deoxyribonucleic acid (DNA) vaccine (IGFBP-2 vaccine) and combination chemotherapy work in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. IGFBP-2 is a protein found in the blood and tumor cells of most who have been diagnosed with ovarian cancer. Too much IGFBP-2 has been associated with more invasive disease. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells that express IGFBP-2. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving IGFBP-2 vaccine and combination chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery.
详细描述
PRIMARY OBJECTIVES:
I. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases the rate of complete pathologic response (CR).
SECONDARY OBJECTIVES:
I. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases progression free survival at 12 months.
II. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy improves overall survival.
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
- •Patients with newly diagnosed advanced stage (III/IV) ovarian cancer (ovarian/fallopian tube/peritoneal cancer) who have been recommended to receive neoadjuvant carboplatin/paclitaxel chemotherapy with subsequent cytoreductive surgery
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2
- •Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
- •Estimated life expectancy of more than 6 months
- •White blood cells (WBC) >= 3000/mm^3 within 30 days of enrollment to study
- •Hemoglobin (Hgb) >= 10 g/dl within 30 days of enrollment to study
- •Hematocrit (Hct) >= 28% within 30 days of enrollment to study
- •Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min within 30 days of enrollment to study
- •Total bilirubin =< 2.5 mg/dl within 30 days of enrollment to study
- •Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN) within 30 days of enrollment to study
- •Blood glucose <1.5 ULN within 30 days of enrollment to study
- •All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study
- •Patients must be at least 18 years of age
排除标准
- •Patients with any of the following cardiac conditions:
- •Symptomatic restrictive cardiomyopathy
- •Unstable angina within 4 months prior to enrollment
- •New York Heart Association functional class III-IV heart failure on active treatment
- •Symptomatic pericardial effusion
- •Uncontrolled diabetes
- •History of (non-infectious) pneumonitis that required steroids or current pneumonitis
- •Patients with any contraindication to receiving rhuGM-CSF based products
- •Patients with any clinically significant autoimmune disease uncontrolled with treatment
- •Patients who are currently receiving an anti-IGF-IR monoclonal antibody as part of their treatment regimen
- •Patients who are simultaneously enrolled in any other treatment study
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
Treatment (chemotherapy, IGFBP-2 vaccine)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.
干预措施: Carboplatin (Drug)
Treatment (chemotherapy, IGFBP-2 vaccine)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.
干预措施: Gynecological Surgical Procedure (Procedure)
Treatment (chemotherapy, IGFBP-2 vaccine)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (chemotherapy, IGFBP-2 vaccine)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.
干预措施: Paclitaxel (Drug)
Treatment (chemotherapy, IGFBP-2 vaccine)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.
干预措施: pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine (Biological)
结局指标
主要结局
Rate of Pathologic Complete Response (CR)
时间窗: At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)
The tissue collected at time of cytoreductive surgery, post study treatment, was evaluated by the attending pathologist assigned to look at the tissue for viable tumor cells. The corresponding surgical pathology report was reviewed to evaluate individual pCR (absence of viable tumor cells).
次要结局
- Overall Survival (OS)(Up to 5 years)
- Immunohistochemistry (IHC) Staining for CD3, CD4, CD8, and CD27(At the time of cytoreductive surgery)
- Level of IGFBP-2 Th1 Cells Elicited With Vaccine Assessed by Enzyme-linked Immunosorbent Spot Assay(Up to 6 months after last vaccine)
- Level of Tumor Infiltrating Lymphocytes (TIL) in Tumor(At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.))
- Progression Free Survival (PFS)(Up to 12 months)
- Tumor Burden(At the time of cytoreductive surgery)
研究者
Mary (Nora) Disis
Professor, Department of Medicine, Division of Oncology
University of Washington