NCT02772562终止2 期
A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy
研究概览
简要总结
The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.
详细描述
This study is for adult male patients who have recently undergone radical prostatectomy and are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational drug.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Completed radical prostatectomy for pathologically-verified adenocarcinoma of the prostate no more than 120 days prior to start of treatment. The following procedures are acceptable: radical retropubic prostatectomy (RRP), laparoscopic radical prostatectomy (with or without robotic assistance; LAPD), radical perineal prostatectomy (RPP).
- •Post-operative PSA <0.2ng/mL by 120 days after prostatectomy
- •Must have one or more of the following:
- •pT3b or pT4 primary tumor
- •Gleason score 8-10
- •pN1 lymph node disease
- •positive surgical margins
- •pre-operative PSA of > 10ng/mL
- •presence of any tertiary Gleason 5 component on the prostatectomy pathology report.
- •Note: Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled.
- •ECOG performance status 0-1
- •Adequate hematologic, renal, liver function per parameters in Table 1
- •Subject of fathering potential must agree to use an adequate method of contraception to avoid conception throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy.
- •Subjects must have had a negative bone scan, and CT of abdomen and pelvis within 16 weeks prior to registration. Additional forms of imaging (Prostascint scan, MRI) may be substituted for a CT scan of the abdomen and pelvis if clinically indicated.
排除标准
- •Pure small cell carcinoma of the prostate
- •Radiographically-demonstrable metastases at any time prior to the time of enrollment
- •Diagnosis of cancer requiring systemic therapy in the past 5 years
- •Presence of any major medical condition which, in the opinion of the investigator, precludes participation in the study
- •Neoadjuvant or adjuvant therapy of any kind
- •Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic glucocorticoids within 28 days of the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal sprays, and all topical preparations (creams, solutions, gels, ointments, etc.) for up to 5% of the body surface area is allowed.
- •Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids, TNF antagonists, antibodies to IL6 or IL6R, calcineurin inhibitors, mTOR antagonists
- •Prior history of serious toxicity or a systemic reaction to vaccinia immunization such as myopericarditis progressive vaccinia infection, or eczema vaccinatum.
- •Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt epidermis
- •Active infections requiring systemic therapy
- •Serologic evidence of HIV/AIDS.
- •Positive hepatitis C serology or active hepatitis B infection.
- •History of allergy to eggs, egg products, aminoglycoside antibiotics
- •History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart failure, ischemic cardiomyopathy
- •Prior solid organ or stem cell transplant
- •History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus, localized lupus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, or Addison's disease). Persons with vitiligo, Hashimoto's thyroiditis, or Graves disease are not excluded.
- •Vaccination with live attenuated vaccine within 28 days prior to day 1 of PROSTVAC-V/F administration or vaccination with a killed vaccine within 14 days prior to day 1 of PROSTVAC-V/F.
- •Inability to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination or until the vaccination site heals completely: (a) children ≤ 3 years of age; (b) pregnant or nursing women; (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders; or (d) immunocompromised individuals, such as those with HIV.
- •Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including Follow-Up), or would interfere with the evaluation of the trial endpoints.
研究组 & 干预措施
PROSTVAC-V/F
Experimental
干预措施: PROSTVAC-V/F (Biological)
结局指标
主要结局
Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy
时间窗: 2 years
RFS is defined as the absence of relapse (PSA ≥ 0.2 ng/mL confirmed \>30 days later, radiographic metastasis, initiation of new prostate cancer therapy, or death) at 2 years after prostatectomy. The measure represents the proportion of participants who remain relapse-free at 24 months post-surgery.
次要结局
- Comparison of Observed vs. Predicted RFS(2 years)
- Observed Relapse Free Survival (RFS) With the RFSs of a Historical Comparison Group of MUSC Prostatectomy Patients.(2 years)
- Associations Between RFS Values and Research Specimen(2 years)
研究者
研究点 (1)
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