NCT02555397已完成1 期
Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dose-dependent Toxicity
研究概览
简要总结
The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy
- •Evidence of biologically active disease as demonstrated by an unequivocally rising serum PSA level that is ≥ 2 ng/mL above the nadir
- •PSA < 100 ng/mL
- •Age ≥ 18 years
- •Karnofsky performance status ≥ 70
- •Negative lymph nodes as established by imaging (pelvic CT or pelvic MRI)
- •No evidence of metastatic disease, as evaluated by bone scan and CT scan of the abdomen and pelvis.
- •Subjects must have adequate baseline organ function as assessed by the the following laboratory values:
- •Adequate renal function with serum creatinine ≤ 1.5 mg/dL
- •Platelet count > 100,000/µL
- •Absolute neutrophil count > 1,000/µL
- •Hemoglobin > 10.0 g/dL
- •Bilirubin > 1.5 mg/dL
- •AST/SGOT and ALT/SGPT < 3.0 times upper limit of normal (ULN)
- •Men of child-producing potential must be willing to consent to use effective contraception for at least 3 months after the gene therapy
- •Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study
排除标准
- •PSA ≥ 100 ng/mL
- •Prostate volume > 100 cc
- •Pathologically positive lymph nodes or nodes > 1.0 cm on imaging (nodes > 1.0 cm but biopsy negative are allowed.
- •Evidence of M1 metastatic disease
- •Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment. Subjects must be disease-free for > 5 years
- •Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
- •If the subject had prior androgen deprivation therapy (ADT), the subject exhibited biochemical failure while on ADT
- •Prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowed; however, subjects must be > 2 years post-completion of chemotherapy at the time of registration. Subjects on Proscar therapy must stop to be eligible)
- •Major surgery planned within 3 months of registration
- •Severe, active co-morbidity defined as:
- •New York Health Association Class II or greater congestive heart failure or active ventricular arrhythmia requiring medication
- •Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within last 3 months or precluding study therapy at the time of registration
- •Acute infection
- •Previous history of liver disease including hepatitis
- •Immunosuppressive therapy including systemic corticosteroids (use of inhaled and topical corticosteroids is permitted)
- •Impaired immunity or susceptibility to serious viral infections
- •Allergy to any product used in the protocol. If the subject has an allergy to Ciproflaxin, another antibiotic can be substituted at the discretion of the treating physician
- •Serious medical or psychiatric illness or concomitant medication, which, in the judgement of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial
研究组 & 干预措施
Single
Experimental
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.
干预措施: Ad5-yCD/mutTKSR39rep-hIL12 (Biological)
结局指标
主要结局
Dose-dependent Toxicity
时间窗: 30 days from date of adenovirus injection (defined as day 1)
次要结局
- Quality of Life (QOL)(2 years)
- PSA Doubling Time (PSADT)(2 years)
- Disease-specific and Overall Survival(5 years)
- PSA Response(2 years)
- Freedom From Biochemical/Clinical Failure (FFF)(2 years)
研究者
Farzan Siddiqui
Senior Staff Physician
Henry Ford Health System
研究点 (1)
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