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NCT00453336 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-02-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment

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outcome · POSTED

Number of Participants Experiencing Adverse Events

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Porfimer Sodium
    2. Procedure: Photodynamic Therapy
    label
    Single Arm
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Single Arm
    description
    Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
    name
    Porfimer Sodium
    other Names
    1. Photofrin
    type
    DRUG
  2. arm Group Labels
    1. Single Arm
    description
    Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
    name
    Photodynamic Therapy
    other Names
    1. Microlens Diffuser P/N 5416
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
45
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
    measure
    Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
    time Frame
    6 months
  2. description
    Number of participants enrolled experiencing serious adverse events and/or other non-serious events
    measure
    Number of Participants Experiencing Adverse Events
    time Frame
    6 months
Full study description
brief 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.
detailed Description
OBJECTIVES: * Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract. * Determine the safety of this regimen in these patients. OUTLINE: Patients are stratified according to disease condition (benign vs malignant). Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4. After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Source references
references
  1. citation
    Civantos F. Photodynamic therapy for head and neck lesions in the subtropics. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S65-8. doi: 10.6004/jnccn.2012.0179.
    pmid
    23055220
    type
    RESULT
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      source record id
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-d2603aa58ddefd46c4ac
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      nct id
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      occurrences
      1. context exact
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        11
        exact text
        NCT00453336
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
      Source null
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      parsed_JSON_string_unmodified
      source string sha256
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    Preserved source evidence · Not medical advice