Head and Neck Cancer
Conditions
Keywords
recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage 0 laryngeal cancer, stage 0 lip and oral cavity cancer
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, 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.
Detailed description
OBJECTIVES: * To determine the response of patients with recurrent dysplasia, squamous cell carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated with photodynamic therapy using porfimer sodium. * To identify the local toxicity of this treatment in these patients. OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of disease may receive another dose of laser light on day 5 without additional porfimer sodium. Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the initial treatment. After completion of study therapy, patients are followed for 1-2 months.
Interventions
DRUGporfimer sodium
IV
DRUGPhotdynamic Therapy (PDT)
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response | 2 years | Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia. |
| Local Toxicity | 30 days | Number of patients with an adverse event |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Porfimer Sodium Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
porfimer sodium: IV | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease Progression | 4 |
| Overall Study | Other Not Specified | 2 |
| Overall Study | Physician Decision | 4 |
Baseline characteristics
| Characteristic | Porfimer Sodium |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 60.8 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 30 |
| serious Total, serious adverse events | 3 / 30 |
Outcome results
Primary
Local Toxicity
Number of patients with an adverse event
Time frame: 30 days
Population: All treated and eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Porfimer Sodium | Local Toxicity | 29 participants |
Primary
Response
Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.
Time frame: 2 years
Population: All treated and eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Porfimer Sodium | Response | 3.5 percentage of participants |