Phase 2 Completed N=45 Treatment

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

Head and Neck Cancer · Precancerous/Nonmalignant Condition

Source: ClinicalTrials.gov NCT00453336 ↗

Enrolled (actual)

Serious AEs

53.3%

Results posted

Oct 2013

Primary outcomePrimary: Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment — 32 participants

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, precancerous cells and cancer cells are killed. PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment	32	—
PRIMARY Number of Participants Experiencing Adverse Events	36	—

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:
Any of the following benign lesions:
Localized severe dysplasia, leukoplakia, erythroplakia, or other superficial lesions considered to be pre-malignant
Carcinoma in situ
Superficial (< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx
T1-T3 disease
Meets one of the following criteria:
Failed radiation therapy and refused standard salvage surgery
Refused radiation therapy and/or surgery as primary therapy
No good surgical alternative with acceptable morbidity
Condemned mucosa syndrome
At least one upper aerodigestive tract pre-malignant lesion, carcinoma in situ, or squamous cell carcinoma previously treated with surgery and/or radiation therapy with the development of another lesion not at the site of the previously treated areas

PATIENT CHARACTERISTICS:

Creatinine ≤ 2 mg/dL
AST and ALT ≤ 30% elevated
Alkaline phosphatase ≤ 30% elevated
Bilirubin ≤ 1.0 mg/dL
No contraindication to anesthesia or analgesia
No porphyria
No hypersensitivity to porphyrins
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00453336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.