Status:
COMPLETED
Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective ...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carci...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy-confirmed diagnosis of 1 of the following:
- Mild to severe dysplasia of the larynx
- Dysplastic lesions \> 3 mm in thickness
- Squamous cell carcinoma in situ of the larynx
- T1 squamous cell carcinoma of the larynx
- Tumor \> 3 mm in thickness
- No T2-T4 squamous cell carcinoma of the larynx
- Newly diagnosed or recurrent disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Total bilirubin \> 2.0 mg/dL
- Creatinine \> 2.0 mg/dL
- SGOT \> 3 times upper limit of normal (ULN)
- Alkaline phosphatase \> 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
- No porphyria
- No hypersensitivity to porphyrin or porphyrin-like compounds
- PRIOR CONCURRENT THERAPY:
- Any prior therapy allowed
- At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
April 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00675233
Start Date
April 25 2008
End Date
September 27 2018
Last Update
October 17 2018
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001