NCT01606241已完成1 期
A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope Folate Receptor Alpha Peptide Vaccine Used in Combination With Cyclophosphamide in Subjects Previously Treated for Breast or Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of patients who experience severe toxicities (grades 3-5 of the National Cancer Institute's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0)
研究概览
简要总结
This phase I clinical trial studies the side effects of vaccine therapy and cyclophosphamide in treating patients with stage II-III breast cancer or stage II-IV ovarian, primary peritoneal or fallopian tube cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, 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 vaccine therapy and cyclophosphamide may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety of administering one cycle of cyclophosphamide and six subsequent monthly vaccinations with a peptide-based vaccine targeting folate receptor (FR)-alpha (multi-epitope folate receptor alpha peptide vaccine).
II. To assess the ability of this vaccination protocol to elicit an immune response as measured by activated FR-alpha-specific T lymphocytes or high-affinity antibodies.
SECONDARY OBJECTIVES:
I. To determine FR-alpha expression status of primary tumors when available as formalin-fixed, paraffin-embedded material and whether expression correlates with the ability to generate an immune response.
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
- •Clinically confirmed no evidence of disease >= 90 days from completion of systemic therapy with the exception of hormonal therapy and bisphosphonates (per practice guidelines for breast and ovarian cancer)
- •Histological or cytological confirmation of stage II or III breast cancer or stage II, III, or IV ovarian/primary peritoneal/fallopian tube cancer; Note: patients with stage IV ovarian/primary peritoneal/fallopian tube cancer must register within one year of completing chemotherapy
- •Completed systemic treatment (chemotherapy, immune modulators [such as trastuzumab], radiation, and/or corticosteroids) with the exception of hormonal therapy and bisphosphonates >= 90 days prior to registration
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Absolute neutrophil count (ANC) >= 1500/mm^3
- •Platelets >= 100,000/ul
- •Hemoglobin >= 10.0 g/dL
- •Creatinine =< 1.5 x upper limit of normal (ULN) or 24 hour urine =< grade 2
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN
- •Serum albumin >= 3 g/dL
- •Urinalysis with =< 2+ proteinuria
- •Thyroid-stimulating hormone (TSH) - negative or =< normal institutional range
- •Anti-nuclear antibody (ANA) - negative or =< normal institutional range
- •Serum rheumatoid factor (RF) - negative or =< normal institutional range
- •Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •Capable of understanding the investigative nature, potential risks, and benefits of the study and capable of providing valid informed consent
- •Willing to return to Mayo Clinic Rochester for follow-ups (immunizations, blood draws, etc.)
- •Willing to provide mandatory blood samples for primary and correlative goals
- •Willing to receive a tetanus vaccination if you have not had one within the past year
排除标准
- •Any of the following:
- •Pregnant women
- •Nursing women unwilling to stop breast feeding
- •Men or women of childbearing potential who are unwilling to employ adequate contraception from the time of registration through cycle 6 (or the final vaccine cycle for each patient)
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Receiving any other investigational agent
- •Other active malignancy =< 5 years prior to registration; EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (cytotoxics, monoclonal antibodies, small molecule inhibitors) for this cancer
- •Known history of autoimmune disease
- •Any contraindication to receiving sargramostim (GM-CSF) or cyclophosphamide
- •Uncontrolled acute or chronic medical conditions including, but not limited to the following:
- •Active infection requiring antibiotics
- •Congestive heart failure (New York Heart Association class III or IV; moderate to severe objective evidence of cardiovascular disease)
- •Myocardial infarction or stroke within previous 6 months
- •Use of a systemic steroid =< 30 days prior to registration
- •Receiving thyroid replacement therapy
研究组 & 干预措施
Treatment (cyclophosphamide and vaccine therapy)
Experimental
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of course 1. Within 3-5 days, patients receive multi-epitope folate receptor alpha peptide vaccine ID on day 1. Vaccine treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Cyclophosphamide (Drug)
Treatment (cyclophosphamide and vaccine therapy)
Experimental
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of course 1. Within 3-5 days, patients receive multi-epitope folate receptor alpha peptide vaccine ID on day 1. Vaccine treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (cyclophosphamide and vaccine therapy)
Experimental
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of course 1. Within 3-5 days, patients receive multi-epitope folate receptor alpha peptide vaccine ID on day 1. Vaccine treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Multi-epitope Folate Receptor Alpha Peptide Vaccine (Biological)
结局指标
主要结局
Proportion of patients who experience severe toxicities (grades 3-5 of the National Cancer Institute's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0)
时间窗: Up to 12 months
Defined as adverse events that are classified as either unrelated, unlikely to be related, possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed by primary disease site to determine toxicity patterns.
次要结局
- Percentage change in plasma concentration of cytokines and chemokines(Baseline to up to 12 months)
- Disease-free survival(Time from registration to documentation of disease recurrence, second primary, or death without disease recurrence or second primary, assessed up to 12 months)
- FRa expression(Up to 12 months)
- Overall survival time(Time from registration to death due to any cause, assessed up to 12 months)
研究者
研究点 (1)
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