Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT02068157
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02068157
Study Brief:
Protocol Section:
NCT02068157