Head and Neck Cancer, Precancerous/Nonmalignant Condition
Conditions
Keywords
recurrent squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the oropharynx, oral leukoplakia
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.
Interventions
DRUGPorfimer Sodium
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.
PROCEDUREPhotodynamic Therapy
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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | 6 months | Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0. |
| Number of Participants Experiencing Adverse Events | 6 months | Number of participants enrolled experiencing serious adverse events and/or other non-serious events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Photodynamic Therapy : 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.
Porfimer Sodium : 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. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 66 years |
| Gender Female | 23 Participants |
| Gender Male | 22 Participants |
| Pathology Carcinoma in situ | 9 participants |
| Pathology Severe Dysplasia | 13 participants |
| Pathology Squamous Cell Carcinoma | 22 participants |
| Pathology Verrucous Carcinoma | 1 participants |
| Region of Enrollment United States | 45 participants |
| Types of Lesions Layngeal Lesions | 18 participants |
| Types of Lesions Oral Cavity Lesions | 24 participants |
| Types of Lesions Other Lesions | 3 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 45 |
| serious Total, serious adverse events | 24 / 45 |
Outcome results
Primary
Number of Participants Experiencing Adverse Events
Number of participants enrolled experiencing serious adverse events and/or other non-serious events
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Number of Participants Experiencing Adverse Events | 36 participants |
Primary
Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | 32 participants |