Status:
TERMINATED
Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. PURPO...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose in the oral cavity of photodynamic therapy (PDT) using HPPH and 665 nm light in patients with recurrent dysplasia, carcinoma in situ, or...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy-confirmed diagnosis of 1 of the following:
- Mild to severe dysplasia
- Carcinoma in situ (CIS) of the oral cavity
- Carcinoma must be less than 3mm thick
- Stage I (T1) squamous cell carcinoma of the oral cavity
- Recurrent or primary disease
- No T2 or greater squamous cell carcinoma, exophytic CIS, or dysplasia lesions
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Total bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase ≤ 3 times the upper limit of normal (ULN)
- SGOT ≤ 3 times ULN
- Not pregnant
- Fertile patients must use effective contraception
- No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- PRIOR CONCURRENT THERAPY:
- Prior therapy of any type allowed
- More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00670397
Start Date
June 1 2010
End Date
July 1 2015
Last Update
March 16 2016
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001