A Phase II Study of (IGFBP-2) Vaccine to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
This phase II trial studies how well giving the insulin-like growth factor binding protein 2 [pUMVC3-hIGFBP-2 multi-epitope plasmid deoxyribonucleic acid (DNA) (IGFBP-2)] vaccine after one dose of carboplatin works to stop ovarian cancer from growing, spreading, or getting worse (progressing) in patients whose cancer recurrence is detected only in the blood (serologic detection) following treatment with platinum chemotherapy. IGFBP-2 is a protein found in ovarian cancer cells. The IGFBP-2 vaccine may help the body build an effective immune response to kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It has been shown to activate parts of the immune system that may act against tumors. Giving the IGFBP-2 vaccine after a single dose of carboplatin may be an effective way to stop ovarian cancer from progressing in patients with serologic detection following treatment with platinum chemotherapy.
详细描述
OUTLINE:
Patients receive a single dose of carboplatin intravenously (IV) per standard of care on day -3 or -2 prior to cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, computed tomography (CT), and/or magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up at 4 weeks, every 4 weeks for 1 year, and then every 6 months for 2 years.
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
- •Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy
- •Have a cancer antigen 125 (CA-125) that normalized after first-line therapy
- •CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment
- •Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Ascites and pleural effusions are not measurable disease, if asymptomatic
- •All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study (end of one year follow up). Note: Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal
- •Have estimated life expectancy of at least 3 months
- •Be willing and able to provide written informed consent/assent for the trial
- •Be ≥ 18 years of age on day of signing informed consent
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- •White blood cell (WBC) ≥ 3000/mm^3 (performed within 14 days of treatment initiation)
- •Hemoglobin (Hgb) ≥ 10 g/dl (performed within 14 days of treatment initiation)
- •Hematocrit (Hct) ≥ 28% (performed within 14 days of treatment initiation)
- •Serum creatinine ≤ 2.0 mg/dl or creatinine clearance > 60 mL/min (performed within 14 days of treatment initiation)
- •Total bilirubin ≤ 2.5 mg/dl (performed within 14 days of treatment initiation)
- •Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal (ULN) (performed within 14 days of treatment initiation)
- •Blood glucose < 1.5 ULN (performed within 14 days of treatment initiation)
排除标准
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment (i.e., day 1)
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (if dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- •Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events [irAEs]) is allowed
- •Has symptomatic ascites or pleural effusions
- •History of borderline or low malignant potential ovarian cancer
- •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- •Has had prior chemotherapy, biologic therapy, targeted small molecule therapy, hormonal therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent
- •Note: Patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study
- •Note: If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- •Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
- •Has an active infection requiring systemic therapy
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
- •Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
- •Clinically significant cardiovascular disease
- •Known severe hypersensitivity reactions to carboplatin ≥ grade 3, any history of anaphylaxis, or uncontrolled asthma
- •Patients with any contraindication to receiving recombinant human granulocyte macrophage-colony stimulating factor (rhuGM-CSF) based products
- •Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- •Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis c virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
- •Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed
- •Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
研究组 & 干预措施
Treatment (carboplatin, IGFBP-2 vaccine)
Patients receive a single dose carboplatin IV per standard of care on day -3 or -2 of cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, CT, and/or MRI throughout the study.
干预措施: Carboplatin (Drug)
Treatment (carboplatin, IGFBP-2 vaccine)
Patients receive a single dose carboplatin IV per standard of care on day -3 or -2 of cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, CT, and/or MRI throughout the study.
干预措施: Biospecimen Collection (Procedure)
Treatment (carboplatin, IGFBP-2 vaccine)
Patients receive a single dose carboplatin IV per standard of care on day -3 or -2 of cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, CT, and/or MRI throughout the study.
干预措施: Computed Tomography (Procedure)
Treatment (carboplatin, IGFBP-2 vaccine)
Patients receive a single dose carboplatin IV per standard of care on day -3 or -2 of cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, CT, and/or MRI throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (carboplatin, IGFBP-2 vaccine)
Patients receive a single dose carboplatin IV per standard of care on day -3 or -2 of cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, CT, and/or MRI throughout the study.
干预措施: pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine (Biological)
结局指标
主要结局
Progression free survival
时间窗: At 6 months
Will compare the progression free survival based on radiographic imaging at 6 months to historical control rates for this population of patients treated by letrozole or tamoxifen. The comparison of the observed rate of progression free survival at 6 months to the benchmark rate will be conducted by Fisher's exact test. The Kaplan-Meier survival curve will be plotted and the median progression free survival will be compared to the historical progression free survival with Greenwood confidence interval.
次要结局
- Radiographic recurrence rate(At 6 months)
- Predictive value of insulin-like growth factor-binding protein 2 (IGFBP-2) positivity toward the rate of progression free survival(At baseline, 4 weeks post-last vaccine, and 6 months post-first vaccine)
- T-cell response and IGFBP-2 accuracy of predicting clinical response(At baseline, 4 weeks post-last vaccine, and 6 months post-first vaccine)