NCT00880854撤回1 期
Phase I Dose-escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) for Patients With BCG-resistant Localized Transitional Cell Carcinoma of the Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ
研究概览
简要总结
The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial bladder cancer after standard BCG treatment.
In addition, the study will look to see if taking CP 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.
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
- •Histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical BCG.
- •Evidence of disease recurrence within 1 year of previous BCG treatment
- •Tumor tissue must be available from biopsy for study related immunohistochemical analysis
- •If sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment
- •ECOG performance status of <2
- •Life expectancy of at least 6 months
- •Adequate hematologic, renal and liver function
- •Informed consent
排除标准
- •No evidence of immunosuppression or treated with immunosuppressive therapy within 6 months
- •No prior radiation to the pelvis
- •No gross hematuria within 1 week prior to planned week 1 treatment
- •Cannot have previous intolerance to BCG
- •Cannot be seropositive for HIV, hepatitis B(HBV) or hepatitis C(HCV) per patient history
- •No evidence of metastatic disease
- •No prior treatment with anti-CTLA-4 monoclonal antibody
- •Can not be pregnant or lactating
- •No history of autoimmune disorder
- •No history of thyroid or adrenal insufficiency
- •No history of inflammatory bowel conditions, including diverticulitis, ulcerative colitis, Crohn's or celiac disease, intractable urinary tract infection
研究组 & 干预措施
1
Experimental
BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 in combination with CP-675,206 I.V. week 3, week 1
干预措施: BCG and CP-675,206 (Drug)
结局指标
主要结局
To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ
时间窗: 24 months
次要结局
- To determine the 1-year recurrence-free survival(24 months)
- To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses(24 months)
- To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes(24 months)
- To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses(24 months)
- To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose(24 months)
研究者
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