A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT) defined as grade III non-hematologic toxicity or grade IV hematologic toxicity as assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 2.0
研究概览
简要总结
This phase I trial is studying the side effects and best dose of photodynamic therapy with lutetium texaphyrin in treating patients with locally recurrent prostate cancer. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for locally recurrent prostate cancer. Photosensitizing drugs, such as lutetium texaphyrin, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells
详细描述
PRIMARY OBJECTIVES:
I. Determine the dose limiting toxicities and maximum tolerated dose of photodynamic therapy (PDT) using 730 nm light and lutetium texaphyrin in patients with locally recurrent prostate adenocarcinoma who have failed previous definitive radiotherapy.
SECONDARY OBJECTIVES:
I. Measure lutetium texaphyrin levels in needle biopsies of the prostate before and after PDT using an HPLC and tissue fluorescence assay and calculate the percent change in lutetium texaphyrin after treatment.
II. Measure lutetium texaphyrin fluorescence in situ in the prostate before and after PDT using optical methods and correlate these results with the direct tissue measurements made in the biopsies of these patients.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven locally recurrent prostate adenocarcinoma previously treated with definitive radiotherapy
- •No T3 or T4 primary tumors
- •No evidence of regional or distant metastases by MRI or bone scan
- •No pathologic demonstration of malignancy in pelvic or abdominal lymph nodes
- •Prostate gland volume no greater than 50 mL by MRI or ultrasound
- •PSA no greater than 20 ng/mL
- •Performance status - ECOG 0-2
- •WBC at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •No severe liver disease (e.g., cirrhosis or grade III-IV elevations in liver function studies)
- •Bilirubin no greater than 1.5 mg/dL
- •Creatinine normal
- •Creatinine clearance at least 60 mL/min
- •Medical suitability for implantation
- •Fertile patients must use effective contraception during and for 6 months after study participation
- •No history of grade III or IV genitourinary or gastrointestinal toxicity
- •No known G6PD deficiency
- •No porphyria
- •At least 4 weeks since prior gene therapy
- •At least 4 weeks since prior immunotherapy
- •At least 4 weeks since prior combination chemotherapy
- •No concurrent chemotherapy
- •At least 4 weeks since prior hormonal therapy
- •No concurrent hormonal therapy
- •No prior cryosurgery for prostate cancer
- •No other concurrent medication for prostate cancer
排除标准
- 未提供
研究组 & 干预措施
Treatment (motexafin lutetium, PDT)
Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy (PDT). Optical fibers attached to a laser are inserted through a catheter into the prostate. The laser delivers 730 nm light to the prostate until the specified fluence is delivered. Patients undergo biopsy of the prostate and bladder before and after PDT. Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
干预措施: motexafin lutetium (Drug)
Treatment (motexafin lutetium, PDT)
Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy (PDT). Optical fibers attached to a laser are inserted through a catheter into the prostate. The laser delivers 730 nm light to the prostate until the specified fluence is delivered. Patients undergo biopsy of the prostate and bladder before and after PDT. Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
干预措施: photodynamic therapy (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT) defined as grade III non-hematologic toxicity or grade IV hematologic toxicity as assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 2.0
时间窗: 24 hours
MTD based on the incidence of DLT as assessed by the Cancer Therapy Evaluation Program CTC version 2.0
时间窗: 24 hours
次要结局
- Percent change in lutetium texaphyrin levels in needle biopsies by high pressure liquid chromatography (HPLC) and tissue fluorescence assay(From pre-PDT to post-PDT)
- Lutetium texaphyrin levels in situ(At pre- and post-PDT)
- Clinical response rate defined as no evidence of disease (NED)(Up to 5 years)
- Progression-free survival (PFS)(From the date of accession to the date of documentation of clinical progression or until the date of death from any cause, assessed up to 5 years)
- Time to complete response(Up to 5 years)
- Time to biochemical relapse(Up to 5 years)
- Time to local progression as determined by clinical exam(From the date of accession to the date of documented local progression, assessed up to 5 years)
- Time to distant failure(From the date of accession to the date of documented metastatic disease, assessed up to 5 years)
- Overall survival(From the date of accession to the date of death, assessed up to 5 years)
- Disease specific survival(Up to 5 years)