Head and Neck Cancer Clinical Trial
Official title:
Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx
Verified date | October 2018 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 treatment for laryngeal cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy
when given together with HPPH in treating patients with dysplasia, cancer in situ, or
invasive cancer of the larynx.
Status | Completed |
Enrollment | 29 |
Est. completion date | September 27, 2018 |
Est. primary completion date | June 28, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity | 6 weeks | ||
Primary | Tumor response | 3 months |
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