Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma
Conditions
Brief summary
This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.
Detailed description
PRIMARY OBJECTIVES: I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients. OUTLINE: Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.
Interventions
DRUGPorfimer Sodium
Given IV
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGPhotodynamic Therapy
Undergo image-guided I-PDT
Sponsors
National Cancer Institute (NCI)
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
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck * Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician) * Patients on chemotherapy &/or targeted agents for palliation * Life expectancy of at least 6 months in the judgment of the physician * Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after the last treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion criteria
* Radiotherapy within the last 2 months in the area to be treated * Patients with known brain metastases should be excluded from this clinical trial * Tumor invading a major blood vessel (such as the carotid artery) * Tumor is not clearly shown on a computed tomography (CT) scan * Location and extension of the tumor precludes an effective I-PDT * Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds * While blood cell (WBC) \< 2.0 x 10\^9/L * Total serum bilirubin \> 2.0 mg/dl * Serum creatinine \> 2 mg/dl * Alkaline phosphatase (hepatic) \> 3 times the upper normal limit * Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper limit of normal * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, acute exacerbation of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female subjects * Unwilling or unable to follow protocol requirements and the light exposure precautions * Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1 | Up to 12 months | Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Alkaline DNase (SADA) Activity | Up to 12 months | SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Porfimer Sodium, Image-guided I-PDT) Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Treatment (Porfimer Sodium, Image-guided I-PDT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 56.1 years STANDARD_DEVIATION 14.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 12 months
Population: All treated and eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Porfimer Sodium, Image-guided I-PDT) | Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1 | 33 percentage of participants |
Secondary
Serum Alkaline DNase (SADA) Activity
SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
Time frame: Up to 12 months
Population: The published assay could not be validated in murine samples. As such, no human samples were analyzed.