NCT00788307终止1 期
Phase I Trial of In Situ Gene Therapy for Locally Recurrent Prostate Cancer Following Radiation Therapy Failure Using Sodium/Iodide Symporter and Radioiodine
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of toxicity incidents by NCI CTCAE v3.0 criteria
研究概览
简要总结
RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to definitive radiation therapy.
详细描述
OBJECTIVES:
Primary
- To determine the safety and tolerance of Ad5CMV-NIS administered intraprostatically followed by radioiodine treatment in patients with locally recurrent adenocarcinoma of the prostate following radiotherapy.
- To determine the maximum tolerated dose of Ad5CMV-NIS in these patients.
Secondary
- To evaluate the PSA response rates, duration, and time to PSA progression in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent adenocarcinoma of the prostate within the past year
- •No transitional cell, small cell, or squamous cell carcinoma of the prostate
- •Local recurrence
- •Disease recurred ≥ 18 months after completion of prior external beam radiotherapy or brachytherapy for stage T1-T3, N0/X, M0 disease
- •Biochemical failure as defined by the Phoenix definition (rise in PSA by 2 ng/mL or more above the nadir PSA)
- •PSA ≥ 0.3 ng/mL to < 20 ng/mL measured within the past 30 days
- •Pre-treatment PSA < 50 ng/mL
- •Prior locally recurrent hormone-refractory disease allowed
- •American Urologic Association Obstructive Symptom Index Score ≤ 24
- •No known standard therapy that is potentially curative or definitely capable of extending life expectancy
- •No evidence of or history of metastatic adenocarcinoma of the prostate
- •Negative radiographic metastatic work-up including whole-body radionuclide bone scan, CT and/or MR scan of the pelvis and abdomen, and chest x-ray
- •Patients with suspicious areas on conventional imaging studies are eligible provided they are biopsy negative
- •No known CNS metastases
- •No prostate size > 140 cc
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •ANC ≥ 1,500/μL
- •Platelet count ≥ 100,000/μL
- •Hemoglobin ≥ 8.5 g/dL
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •INR ≤ 1.4 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Thyroid-stimulating hormone 0.3-5.0 μIU/mL and free thyroxine 0.8-1.87 ng/dL
- •Willing to provide biologic specimens and participate in imaging studies as required
- •Willing to maintain a low-iodine diet for 12 days
- •Starting 7 days prior to study virus injection continuing until study day 5
- •No more than 1 of the following renal/genitourinary toxicities:
- •Bladder spasms
- •Dysuria (painful urination)
- •Genitourinary fistula
- •Hemoglobinuria
- •Incontinence
- •Operative injury to bladder and/or ureter
- •Proteinuria
- •Renal failure
- •Uretal obstruction
- •Urinary frequency/urgency
- •Urinary retention
- •Urine color change (not related to other dietary or physiologic cause [e.g., bilirubin, concentrated urine, or hematuria])
- •Other renal/genitourinary toxicities
- •No urinary tract infection within 72 hours prior to registration
- •No pubic arch interference study demonstrating unacceptable prostate access by the transperineal approach
- •No absence of rectum or other anatomic features that would preclude transperineal needle insertion into the prostate
- •No coagulopathy that contraindicates transperineal and intraprostatic needle insertion
- •No other cancer within the past 2 years, except for squamous cell and basal cell skin cancers
- •No uncontrolled infection or fever > 100°F
- •No known cardiac disease
- 另有 18 项未显示
排除标准
- 未提供
研究组 & 干预措施
Experimental Arm
Experimental
干预措施: Ad5-CMV-NIS (Biological)
Experimental Arm
Experimental
干预措施: liothyronine sodium (Drug)
结局指标
主要结局
Number of toxicity incidents by NCI CTCAE v3.0 criteria
时间窗: 3 years
次要结局
- Time to PSA progression(3 years)
- Duration of PSA control(3 years)
- Survival(3 years)
- Incidence and duration of PSA response(3 years)
研究者
研究点 (1)
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