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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT03727061
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* 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.
Exclusion Criteria:
* 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) v1.1.
* 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 \< 75,000.
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03727061
Study Brief:
Protocol Section:
NCT03727061