NCT01118819终止1 期
Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Safety and tolerability of C. novyi-NT spore administration in patients with advanced solid tumor malignancies will be measured over a 7-day inpatient admission with routine labs and continuous adverse event assessments.
研究概览
简要总结
This protocol will examine the safety of intravenous administration of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intravenously in patients with treatment-refractory solid tumor malignancies.
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
- •Diagnosis of an advanced solid tumor malignancy
- •History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment.
- •Measurable disease as defined by RECIST 1.1 criteria.
- •At least 4 weeks has elapsed since the completion of major surgery and the patient is fully recovered from this surgery and any post-surgical complications.
- •ECOG performance status of 2 or less.
- •Patient is at least 18 years of age
- •Patient is capable of giving informed consent.
- •Patient of childbearing potential (defined by the clinical sites' standards) is using adequate birth control measures (e.g., barrier method with spermicide; intrauterine device; implantable or injectable hormonal contraceptives; surgical sterilization) for the duration of the study and will continue to use such precautions for 12 months after receiving treatment.
- •Patient has no significant valvular disease (trace or mild valvular stenosis or regurgitation is allowed).
- •Patient is able to stay within 45 minutes driving time of an emergency room for 28 days following discharge.
- •The patient has a caregiver for 28 days after dosing.
排除标准
- •Positive pregnancy test
- •Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis.
- •Patient has any of the following hematologic parameters: Platelet count equal to or less than 100,000/mm3, Hemoglobin less than 9.0 g/dL, or an ANC less than 1,000 /mm
- •Oxygen saturation (Sp02) of less than 95% on room air.
- •Mean arterial blood pressure of less than 70 mmHg.
- •Glasgow Coma Score of less than
- •Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug.
- •Documented evidence of primary brain malignancy or brain metastases.
- •Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis.
- •Laboratory evidence of hepatic dysfunction indicated by any of the following: bilirubin > 1.5 x the upper limit of normal, AST or ALT above 2.5X the upper limit of normal, alkaline phosphatase above 2.5X the upper limit of normal or an INR greater than 1.
- •Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip).
- •Clinically significant pleural effusion.
- •Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart.
- •Need for ongoing treatment with an immunosuppressive agent.
- •History of solid organ transplantation (with the exception of a corneal transplant > 3 months prior to screening).
- •History of an ischemic insult in the previous 12 months (myocardial infarction, cerebral vascular accident, ischemic tissue from injury, transient ischemic attack, or clinically significant peripheral vascular disease).
- •Patient has a history of venous stasis resulting in venous stasis ulcers or > 2+ edema.
- •History of a significant medical illness deemed by the principal investigator or local investigators as unsuitable for the trial - for example:
- •i. Symptomatic congestive heart failure; ii. Psychiatric Illness/Social Situation that may make study dangerous; and iii. Unstable angina pectoris.
- •Antibiotic allergies which would preclude treatment for a C. novyi-NT infection, in the event that antibiotics are required.
- •Treatment with antibiotics within 2 weeks (14 days) of dosing.
- •Active and clinically significant systemic or localized infection.
结局指标
主要结局
Safety and tolerability of C. novyi-NT spore administration in patients with advanced solid tumor malignancies will be measured over a 7-day inpatient admission with routine labs and continuous adverse event assessments.
时间窗: 2 years
次要结局
- Anti-tumor activity of C. novyi-NT spores will be assessed with serial imaging studies such as CT scans and blood-based tumor markers.(2 years)
- Pharmacokinetics of the C. novyi-NT spores will be measured in routine blood sampling over the course of the study.(2 years)
- The host immune and inflammatory response to C. novyi-NT spores will be measured in routine blood sampling over the course of the study.(2 years)
研究者
研究点 (4)
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