Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
研究概览
简要总结
This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.
OUTLINE:
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.
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
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck
- •Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
- •Patients on chemotherapy &/or targeted agents for palliation
- •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 6 months after the last treatment; 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 or legal representative 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
- •Radiotherapy within the last 2 months in the area to be treated
- •Patients with known brain metastases should be excluded from this clinical trial
- •Tumor invading a major blood vessel (such as the carotid artery)
- •Tumor is not clearly shown on a computed tomography (CT) scan
- •Location and extension of the tumor precludes an effective I-PDT
- •Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
- •While blood cell (WBC) < 2.0 x 10^9/L
- •Total serum bilirubin > 2.0 mg/dl
- •Serum creatinine > 2 mg/dl
- •Alkaline phosphatase (hepatic) > 3 times the upper normal limit
- •Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper limit of normal
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, acute exacerbation of 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 and the light exposure precautions
- •Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy
研究组 & 干预措施
Treatment (porfimer sodium, image-guided I-PDT)
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (porfimer sodium, image-guided I-PDT)
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
干预措施: Photodynamic Therapy (Drug)
Treatment (porfimer sodium, image-guided I-PDT)
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
干预措施: Porfimer Sodium (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
时间窗: Up to 12 months
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Serum Alkaline DNase (SADA) Activity(Up to 12 months)