Status:
COMPLETED
A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Dysplasia
Carcinoma of the Oral Cavity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 mg/dl, serum creatinine;: 2 mg/dl)
- Unwilling or unable to follow protocol requirements.
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug and or light treatment.
- Patients on concurrent chemotherapy or radiation therapy or less than 4 weeks after the last dose of chemotherapy or radiation therapy.
- Inclusion of Women and Minorities:
- Both men and women and members of all races and ethnic groups are eligible for this study.
Key Trial Info
Start Date :
June 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01140178
Start Date
June 8 2010
End Date
October 1 2018
Last Update
October 16 2018
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263