Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
Stopped early · Phase 2
Conditions studied: Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma
In brief
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.
Key facts
- Study ID
- NCT02068157
- Run by
- Roswell Park Cancer Institute
- People needed
- 3
- Starts
- 2014-04-01
- Expected to finish
- 2016-11-04
- Last updated by the study team
- 2017-10-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.