A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment of Patients With Locally Advanced or Recurrent Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
研究概览
简要总结
This phase I trial studies the side effects of interstitial photodynamic therapy (I-PDT) in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor.
In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety of porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) .
- To determine the recommended light irradiance dose for a future Phase 2 trial of Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC
EXPLORATORY OBJECTIVES:
I . To access the objective tumor response rate
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
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Patients with locally advanced or recurrent head and neck cancer who failed to respond to standard therapy and are not amenable to standard curative treatment.
- •Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician).
- •Life expectancy of at least 6 months, in the judgment of the physician.
- •Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., 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 she or her partner is participating in this study, she should inform her treating physician immediately.
- •Subject must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
排除标准
- •High dose curative radiotherapy within 30 days in the area to be treated. Tumor invading a major blood vessel.
- •Tumor is not measurable on a computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Location and extension of the tumor precludes a potentially effective I-PDT.
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds.
- •Platelet count < 75,
- •Total serum bilirubin > 2 mg/dL
- •Alkaline phosphatase (hepatic) > 3 times the upper normal limit
- •Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 3 times the upper normal limit
- •Patients with moderately to severely impaired creatinine clearance (crcl < 44) will be excluded.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or nursing female subjects.
- •Unwilling or unable to follow protocol requirements.
- •Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive porfimer sodium
研究组 & 干预措施
Arm A(porfimer sodium, I-PDT
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
干预措施: Nivolumab (Biological)
Arm A(porfimer sodium, I-PDT
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
干预措施: Porfimer Sodium (Drug)
Arm A(porfimer sodium, I-PDT
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
干预措施: Interstitial Illumination Photodynamic Therapy (Procedure)
Arm A(porfimer sodium, I-PDT
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
干预措施: Quality of Life Assessment (Other)
结局指标
主要结局
Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
时间窗: Up to 30 days
The frequency of toxicities will be tabulated by max grade of any Adverse Events experience by a patient across dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.
次要结局
未报告次要终点