Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Vical
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Disease recurrence
研究概览
简要总结
RATIONALE: Inserting the gene for interleukin-2 into a person's cancer cells may improve the body's ability to fight cancer. Using Leuvectin to deliver this gene may be an effective treatment for prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of Leuvectin followed by surgery in treating patients who have stage II or stage III prostate cancer.
详细描述
OBJECTIVES:
- Assess the toxicity and tolerability of neoadjuvant Leuvectin in patients with stage II or III prostate cancer.
- Evaluate the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population.
OUTLINE: This is a multicenter study.
Patients receive Leuvectin intraprostatically over 10-30 seconds under ultrasound guidance on day 0 followed by a second injection between days 4 and 7. Between days 8 and 14, patients undergo retropubic prostatectomy.
All patients are followed at 2 months. Patients with a PSA no greater than 0.2 ng/mL are followed at 4 months and 6 months, every 3 months for 12 months, and then every 6 months for 3.5 years in the absence of disease progression or biochemical failure.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage II or III organ confined prostate cancer
- •Resectable disease (candidate for retropubic prostatectomy)
- •Gleason score at least 6
- •Prostate specific antigen value (PSA) at least 5 ng/mL
- •No significant central nervous system (CNS) disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 80-100%
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •White blood cell count (WBC) greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 9.0 g/dL
- •Bilirubin normal; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal
- •Prothrombin time (PT)/partial thromboplastin time (PTT) normal
- •Albumin greater than 3.0 g/dL
- •Hepatitis B surface antigen negative
- •Creatinine normal
- •Cardiovascular
- •No uncontrolled hypertension
- •No significant cardiovascular disease
- •No history of ventricular dysfunction or arrhythmia
- •No congestive heart failure
- •No symptoms of coronary artery disease
- •No prior myocardial infarction
- •No active autoimmune disease
- •No active infection requiring parenteral antibiotics
- •HIV negative
- •No significant psychiatric disorder that would preclude compliance
- •No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer
- •No diabetes mellitus
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for prostate cancer
- •At least 5 years since other prior chemotherapy
- •Endocrine therapy
- •No prior glucocorticoids for prostate cancer
- •At least 5 years since other prior glucocorticoids
- •Radiotherapy
- •No prior radiotherapy for prostate cancer
- •At least 5 years since other prior radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior intrathoracic or intrabdominal surgery
- 另有 6 项未显示
排除标准
- 未提供
研究组 & 干预措施
Leuvectin
2 intratumoral injections of 1000 ug of Leuvectin
干预措施: Leuvectin (Biological)
结局指标
主要结局
Disease recurrence
时间窗: 2 years
Measure timing and rate of disease recurrence
次要结局
- Safety of Leuvectin