Recent literature suggests that certain patients with squamous cell cancers of the head and neck region may benefit from photodynamic therapy whether or not they may have received prior therapy, e.g. radiation therapy
We propose to initiate a Phase 1 a clinical trial using HPPH and 665 nm light in patients with cancer of the oral cavity and/or oropharynx, including lesions of moderate to severe dysplasia, squamous carcinoma in situ and T1 squamous cells carcinoma. The study will employ a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively. The primary goal is the determination of the maximally tolerated PDT dose. Preliminary evidence for PDT efficacy wil also be obtained.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Given IV
Roswell Park Cancer Institute
Buffalo, New York, United States
Toxicity
To determine the maximally tolerated dose in the oral cavity and/or oropharynx of photodynamic therapy (PDT) using HPPH (2-1 (hexyloxyethyl)-2- devinylpyropheophorbide-a) and 665 nm light.
Time frame: 6 weeks
Tumor response
Time frame: 3 months
Response of dysplasia, CiS and selected patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx using photodynamic therapy (PDT) with HPPH (2-1 (hexyloxyethyl)-2-devinylpyropheophorbide-a) and 665 nm light.
Time frame: 3 months
Amount of HPPH in the blood prior to light treatment.
Time frame: 3 months
Biomarkers, i.e. STAT3 crosslinks and/or activation status of pro-survival signaling molecules before and after PDT treatment.
Time frame: 3 months
To determine non-invasively HPPH fluorescence and blood flow in To determine non-invasively HPPH fluorescence and blood flow in tumor and surrounding normal tissue before and after PDT
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.