A Pilot Study of the Safety and Immunogenicity of Folate Receptor Alpha Peptide-Loaded Dendritic Cell Vaccination in Patients With Advanced Stage Epithelial Ovarian Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
研究概览
简要总结
This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of folate receptor alpha dendritic cell (FRalphaDC) vaccination (folate receptor alpha-peptide loaded dendritic cell vaccine).
SECONDARY OBJECTIVES:
I. Measure time to disease recurrence of patients treated with FRalphaDCs. II. Measure overall survival of patients treated with FRalphaDCs.
TERTIARY OBJECTIVES:
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
- •Histologically confirmed surgical diagnosis of stage IIIC or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; patients with stage III cancer must have had peritoneal metastasis beyond pelvis more than 2 cm in greatest dimension and/or regional lymph node metastasis; NOTE: Histologic confirmation of the primary tumor is required; eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma
- •Completion of cytoreductive surgery and has completed one (and only one) course of platinum-based chemotherapy (5-9 cycles) >= 4 but =< 20 weeks prior to registration; NOTE: cytoreductive surgery may have been prior to or after the first cycle of chemotherapy but must include hysterectomy and bilateral salpingo-oophorectomy, if the uterus and/or ovaries had not previously been removed; NOTE: patients may have had more than one chemotherapy regimen (ex: paclitaxel/carboplatin switched to docetaxel/carboplatin due to allergy; weekly treatment switched to every 3 week treatment due to intolerance), but may not have received a separate course of treatment for recurrent ovarian cancer (OC); NOTE: patients may receive both neoadjuvant and adjuvant chemotherapy provided both regimens are platinum-based and total 9 or fewer chemotherapy cycles
- •No evidence of disease at the time of registration, including no clinical concern for disease recurrence based on each of the following:
- •No evidence of disease by history and physical exam
- •Cancer antigen (CA)125 within normal limits
- •Computed tomography (CT) abdomen/pelvis demonstrating no radiological evidence of disease performed after completion of chemotherapy =< 28 days before entering study
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
- •Platelet count >= 75 x 10^9/L
- •Hemoglobin >= 8.5 g/dL
- •Lymphocytes >= 0.3 x 10^9/L
- •Total bilirubin =< 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin =< 1.0 mg/dL
- •Aspartate transaminase (AST) =< 3 x ULN
- •Creatinine =< 2.0 mg/dL
- •Monocytes >= 0.25 x 10^9/L
- •Able to provide informed written consent
- •Expected survival > 6 months
- •Willingness to return to Mayo Clinic Rochester for follow-up appointments
- •Willingness to provide blood samples for immune assessment and other tests
- •Willingness to undergo a tetanus vaccination
排除标准
- •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 and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- •Uncontrolled intercurrent illness including, but not limited to:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Other uncontrolled intercurrent illness (specify)
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •Other active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- •History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •Epithelial ovarian cancer of low malignant potential (borderline tumor)
- •Treatment with chemotherapy, radiation therapy, or other immunotherapy =< 4 weeks prior to registration
- •Immunosuppressive therapy (excluding topical steroids) for any other condition =< 4 weeks prior to registration
- •Persistent fever (> 24 hours) documented by repeated measurement =< 4 weeks prior to registration
- •Diagnosis of autoimmune disease, including, but not limited to:
- •Systemic lupus erythematosus (lupus)
- •Multiple sclerosis (MS)
- •Rheumatoid arthritis (RA)
- •Ankylosing spondylitis
- •Other autoimmune disease (specify)
- •Use of a systemic steroid (> 5 mg prednisone daily or equivalent) =< 4 weeks prior to registration
研究组 & 干预措施
Treatment (vaccine therapy)
INDUCTION PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 months for 7 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (vaccine therapy)
INDUCTION PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 months for 7 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine (Biological)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
时间窗: Up to 3 weeks
If the accrual schema is completed and there are fewer than 5 patients with a DLT, the vaccination treatment will be considered safe in this patient population.
次要结局
- Overall survival (OS)(Number of days from study registration until death due to any cause, assessed up to 5 years)
- Time to disease recurrence (TDR)(Number of days from study registration until disease recurrence or death, assessed up to 5 years)