Phase 1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety + Tolerability of 2 Instillations of Intravesical SCH 721015 in Admixture with Novel Excipient SCH 209702 (Syn3) on Day 1 and Day 4
研究概览
简要总结
The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. The goal of Part 2 of this study is to learn about the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1 participants who had no sign of bladder cancer after Week 12. The level of effectiveness of SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.
详细描述
The Study Drug:
SCH 72105 is designed to cause "gene transfer" by giving a gene called interferon -alpha-2b into the body. SCH 72105 is made after being processed in the lab with a study drug called Syn3. This combination of study drugs is also called SCH 721015 with Syn3. Syn3 is designed to help the body make a protein called interferon -alpha-2b, and this may help the body's immune system to react against the cancer.
Study Drug Administration:
On Days 1 and 4, SCH 72105 will be given into your bladder over about 1 minute through a urinary catheter. A urinary catheter is a thin flexible tube placed through the urinary tube and into the bladder. SCH 72105 will stay in the bladder for about 1 hour. You will be asked to turn from left to right, back to stomach, every 15 minutes to allow the bladder surface to be exposed to the drug.
A belladonna and opium (B&O) suppository will be inserted into your rectum about 30 minutes before the study drug doses. Levsin SL (hyoscyamine sulfate) will be given by mouth about 15 minutes before the study drug doses. These drugs are used to lower the risk of urinary urgency (a strong need to urinate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- •Histologically proven recurrent urothelial carcinoma of the bladder or prostatic urethra, Stage Tis, Ta
- •Patients with recurrent T1 disease who do not wish to have cystectomy.
- •Subjects must have failed at least two prior courses of BCG with or without recombinant interferon alpha administration or be BCG intolerant. This includes either two six week induction courses of BCG or a 6 week induction course followed by a 3 week mini-induction course of maintenance BCG.
- •At least 3 months must have passed since last BCG therapy or intravesical treatment for bladder carcinoma.
- •Subjects must be 18 years of age or older
- •Life expectancy of at least 3 months
- •Adequate performance status (Karnofsky score >/= 70%)
- •Adequate laboratory values. a) Hemoglobin >/=10 gm/dL. b) White blood cell count (WBC) >/= 3000/µL. c) Absolute neutrophil count (ANC) >/= 1500/µL. d) Platelet count >/=100,000/µL. e) PT </= 1.5 x upper limit of normal (ULN). f) Activated partial thromboplastin time (aPTT) </= 1.5 x ULN. g) AST </=1.5 x ULN. h) ALT </= 1.5 x ULN. i) Total bilirubin </= 1.5 x ULN. j) Creatinine </=1.5 x ULN.
- •Female subjects of childbearing potential (Female subjects who are not surgically sterilized, not at least 1 year postmenopausal) must agree to use adequate contraception (e.g. intrauterine device (IUD), condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: during the study and for at least 1 month prior to drug administration and for 4 months after treatment. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the Study.
- •Male subjects who are sexually active must agree to use a condom from the beginning of treatment and for 1 month after the last dose
排除标准
- •Pregnant or nursing women
- •Suspected hypersensitivity to interferon alpha
- •Participation in another clinical trial or use of any investigational drug within 30 days prior to study entry
- •Subjects with organ transplants
- •Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
- •b. Central nervous system (CNS) trauma or active seizure disorders requiring medication
- •c. Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months
- •d. Poorly controlled diabetes mellitus (HbA1C >10.0%);
- •e. Unstable pulmonary disease requiring hospitalization or emergency room visit within the last 3 months.
- •f. Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
- •Donation of blood within the preceding 60 days prior to study registration.
- •Any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol.
- •History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration
- •Untreated bladder infection
- •Positive for hepatitis BsAg or HIV Ab or hepatitis C
- •Immunosuppressive therapy within the last 3 months
- •Subjects who are part of the staff personnel directly involved with this study
- •Subjects who are family members of the investigational study staff
- •Traumatic catheterization within 1 month
研究组 & 干预措施
First Dose SCH 721015
Part1: 2 Instillations of intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume
干预措施: SCH 721015 (Drug)
Second Dose SCH 721015
Part 2: Subjects who have a complete response to treatment at Week 12 in Part 1 receive second regimen of intravesical administration of SCH 721015 with Syn3 on same Day 1 and Day 4 regimen at same dose level.
干预措施: SCH 721015 (Drug)
结局指标
主要结局
Safety + Tolerability of 2 Instillations of Intravesical SCH 721015 in Admixture with Novel Excipient SCH 209702 (Syn3) on Day 1 and Day 4
时间窗: Daily urine collection for 14 days
次要结局
未报告次要终点