CompletedPhase 1

Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx

United States29 participantsStarted 2008-04-25

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Toxicity

Timeframe: 6 weeks

Tumor response

Timeframe: 3 months

Trial details

NCT IDNCT00675233

SponsorRoswell Park Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06-28