NCT00694798已完成1 期
Open Label, Single Arm, Exploratory Phase I Clinical Trial to Evaluate Efficacy and Safety of Mycobacterium w (Mw) in BCG Refractory Superficial Transitional Cell Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 19
- 主要终点
- Response Rate
研究概览
简要总结
The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety.
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
- •Informed Consent obtained & signed:
- •Ability to understand and the willingness to sign a written informed consent document.
- •Disease characteristics:
- •Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ, multiple unresected T1 and Ta high grade.
- •BCG-refractory STCC is defined as when there is failure to achieve disease-free state at six months after initiation of BCG therapy either as primary or repeat therapy or recurrence of tumor within three months of completion of adequate induction or maintenance therapy or adequate retreatment. .
- •Patient Characteristics:
- •Age: 18 completed years and above Performance status: ECOG 0-2 Life expectancy: At least 24 weeks Hematopoietic:Hemoglobin ≥ 9.0 g/dL
- •Co-morbidity
- •No patient who has eczema will be allowed to participate in this study.
- •Patients who are immuno-compromised will not be enrolled.
- •Patients with severe hepatic dysfunctions or with evidence of Cirrhosis will not be enrolled.
- •Patients with uncontrolled diabetes mellitus will not be enrolled in the study.
- •Note: The effects of Investigational product on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
排除标准
- •Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
- •Intractable urinary tract infection.
- •No patient who has eczema should be allowed to participate in this study.
- •Patients who are immuno-compromised should not be enrolled.
- •Patients with severe hepatic dysfunctions or evidence of Cirrhosis should not be enrolled.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
- •Pregnant women or nursing women are excluded from this study because agents used in the study have potential for teratogenic or abortifacient effects. Because there is known potential risk for adverse events in nursing infants secondary to treatment of the mother with investigational agent, breastfeeding should be discontinued if the mother is treated with investigational product.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Previous splenectomy
- •Clinically significant active infection
- •Patients with uncontrolled diabetes mellitus.
结局指标
主要结局
Response Rate
时间窗: 15 Months
次要结局
未报告次要终点
研究者
研究点 (19)
Loading locations...
相似试验
终止
2 期
Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p DeletionB-cell Chronic Lymphocytic Leukemia (CLL) With 17p DeletionNCT02044822Gilead Sciences102
终止
2 期
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)Lymphoma, Mantle-CellNCT02455297Bayer4
已完成
1 期
Study the Effect of Omeprazole on AB-106 PharmacokineticsPharmacokinetic StudyNCT05609929Nuvation Bio Inc.24
已完成
3 期
The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)Hepatitis C VirusNCT02636595AbbVie121
已完成
1 期
Intracerebral Gene Therapy for Children With Early Onset Forms of Metachromatic LeukodystrophyMetachromatic LeukodystrophyNCT01801709Institut National de la Santé Et de la Recherche Médicale, France5