A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity
研究概览
简要总结
This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers.
SECONDARY OBJECTIVES:
I. To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients.
II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens.
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
- •Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator)
- •Female patients must not be pregnant (documented by human chorionic gonadotropin [HCG] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
- •No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT
排除标准
- •Patients with unresectable tumors
- •Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- •White blood cell (WBC) < 4,000
- •Platelet count < 100,000
- •Prothrombin time 1.5 times above the upper normal limit
- •Total serum bilirubin > 2.0 mg/d
- •Serum creatinine > 2 mg%
- •Alkaline phosphatase (hepatic) > 3 times the upper normal limit
- •Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- •Patients on concurrent chemotherapy or radiation therapy will be excluded
- •Patients who have received radiation therapy, chemotherapy or other biological therapy during the past 30 days
- •Has not recovered from toxicity of prior therapy
研究组 & 干预措施
Treatment (intraoperative PDT)
Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
干预措施: HPPH (Drug)
Treatment (intraoperative PDT)
Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
干预措施: photodynamic therapy (Drug)
Treatment (intraoperative PDT)
Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity
时间窗: 30 days
次要结局
- Uptake and distribution of HPPH in resected tumor tissue(Day 2)
- Time to tumor progression or recurrence(From baseline until objective tumor progression, assessed up to 5 years)