Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
This protocol is evaluating efficacy and toxicity of three sequential whole bladder photodynamic treatment with Photofrin and red laser light (630 nm) in the management of superficial bladder cancer (non-muscle invasive) in those patients who have failed or are not candidates for conventional intravesical therapy.
详细描述
Patient Evaluation and Treatment:
- Patients will sign an IRB-approved informed consent form
- Initial patient assessments will include:
- eligibility
- History and physical.
- clinical profile
- upper urinary tract imaging (if clinically indicated)
- urinary symptoms assessment
WBPDT Treatment:
- Porfimer Sodium (Photofrin) 1.5 mg/kg iv followed 2 days later by whole bladder laser light at 630 nm with target light doses of 1200 Joules (+/-100Joules)
- Patients will undergo three sequential WBPDT treatments
- Treatments will occur at least three months apart
- All WBPDT treatments will occur within 12 months
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
- 是
入选标准
- •Pathological diagnosis of bladder cancer, non muscle invasive
- •Recurrent after at least one course of standard intravesical therapy after transurethral resection (TURBT).
- •Maximum debulking of tumor by TURBT/fulguration
- •One or more of the following:
- •Contraindications to conventional intravesical therapy, including patient's refusal.
- •Positive or suspicious urine cytology localized to the bladder
- •Prior intravesical therapy and persistent atypia.
- •Premalignant (diffuse squamous metaplasia or malakoplakia) lesions.
- •Bladder capacity greater or equal to 150 cc.
- •No contraindications to an appropriate anesthesia or analgesia.
- •Karnofsky's performance status >
- •Patients must sign an informed consent form in accordance with the Institution's Review Board and FDA 21 CFR Part
- •Female patients must be practicing a medically acceptable form of birth control or be sterile or postmenopausal.
排除标准
- •Pregnant or nursing mother.
- •Known hypersensitivity to porphyrins.
研究组 & 干预措施
A single arm, non-randomized Phase II Study
Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.
干预措施: Whole bladder laser light treatment as an alternative to radical cystectomy (Procedure)
A single arm, non-randomized Phase II Study
Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.
干预措施: Photofrin (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 18 months
次要结局
- Disease progression(18 months)
研究者
Unyime O. Nseyo, MD
PHYSICIAN
North Florida/South Georgia Veterans Health System