NCT01924689已完成1 期
Phase I Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 9
- 主要终点
- Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This protocol will examine the safety of intratumoral 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 intratumoral in patients with treatment-refractory solid tumor malignancies.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of an advanced solid tumor malignancy. There must be a target tumor which is measureable, palpable or clearly identifiable under ultrasound or radiographic guidance and amenable to percutaneous injection of C. novyi-NT spores. The targeted lesion must have a longest diameter ≥ 1 cm and ≤ 12 cm and be measurable as defined by RECIST 1.1 criteria. The target lesion must not be located in either the thoracic, abdominal or pelvic cavities or in the brain. There must be no clinical, no functional, and no radiographic evidence of bone involvement at the site of the target lesion.
- •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.
- •At least 4 weeks have elapsed since the completion of major surgery, and the patient has fully recovered from this surgery and any post-surgical complications.
- •Eastern Cooperative Oncology Group (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 heart 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 after doing.
- •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
- •Absolute neutrophil count (ANC) less than 1,000 /mm3
- •Oxygen saturation (Sp02) of less than 95% on room air.
- •Mean arterial blood pressure (BP) of less than 70 mmHg.
- •Glasgow Coma Score (GCS) of less than
- •Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug, whichever is shorter.
- •Documented 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 ULN
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above 2.5X the ULN
- •Alkaline phosphatase above 2.5X the ULN
- •International normalized ratio (INR) greater than 1.3
- •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.
- •History of a significant medical illness deemed by the PI 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 iii. Unstable angina pectoris
- •Antibiotic allergies that would preclude treatment for a C. novyi-NT infection.
- •Treatment with antibiotics within 2 weeks (14 days) of dosing.
- •Active and clinically significant systemic or localized infection.
研究组 & 干预措施
Clostridium novyi-NT spores
Experimental
干预措施: Clostridium novyi-NT spores (Biological)
结局指标
主要结局
Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs)
时间窗: From screening until follow-up visit (up to 12 months)
To determine the DLTs of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection.
Number of Patients With Treatment-emergent Adverse Events (TEAE)
时间窗: From screening until follow-up visit (up to 12 months)
To determine the safety profile of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection. CTCAE: Common Terminology Criteria for Adverse Events
次要结局
- Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans(At screening, at follow up (at 1, 2, 4, and 8 months (±2 days) after dosing))
- Number of Patients With Overall RECIST Response(At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing))
- Number of Patients With Local Tumor-specific T-cell Responses(2 years)
- Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT(At Screening, at Days -1 to 0, at Days 1, 2, 3, 4, 5, 7, at follow up (at 2 months (±2 days) after dosing))
- Number of Patients With RECIST Assessment on the Injected Lesion(At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing))
- Number of Patients With Cytokine Responses Analyzed(2 years)
- Number of Patients With Systemic Tumor Antigen Specific T-cell Responses(2 years)
研究者
研究点 (9)
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