A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Ca… (NCT01140178) | Clinical Trial Compass
CompletedPhase 1
A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx
United States29 participantsStarted 2010-06-08
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
* Patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx.
* Patient may have primary and/or recurrent lesions to be treated.
* Diagnosis must confirmed by biopsy.
* Prior therapy of any type is allowed.
* Male or female patients at least 18 years old. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control or be sterile.
* Patients must have an ECOG score of 0-2 (Appendix A 1 ).
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria:
* Patients with T2 or greater squamous cell carcinoma.
* True tongue base lesions (as determined by the treating physician).
* Patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
* Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
* Patients with impaired hepatic (alkaline phosphatase (hepatic) or SGOT;:3 times the upper normal limits).
* Patients with minimal impairment of renal function (total serum bilirubin;: 2…