TerminatedNot Applicable

Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat

Stopped: new competing studies

United States30 participantsStarted 2001-10

Plain-language summary

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat. PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.

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 oral cavity or larynx lesion with mild-to-severe dysplasia OR in situ or stage I (T1, N0) squamous cell carcinoma of the oral cavity or larynx * Recurrent disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 4,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 2.0 mg/dL * Creatinine ≤ 2.0 mg/dL * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) * SGOT ≤ 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must practice effective contraception * No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: * Any type of prior therapy allowed * More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy

What they're measuring

Response

Timeframe: 2 years

Local Toxicity

Timeframe: 30 days

Trial details

NCT IDNCT00530088

SponsorRoswell Park Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-08

Results submitted2014-01-29