Locally Advanced Head and Neck Carcinoma, Recurrent Head and Neck Carcinoma
Conditions
Brief summary
This phase I trial studies the side effects of interstitial photodynamic therapy (I-PDT) in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor. In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.
Detailed description
PRIMARY OBJECTIVES: I. To determine the safety of porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) . * To determine the recommended light irradiance dose for a future Phase 2 trial of Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC EXPLORATORY OBJECTIVES: I . To access the objective tumor response rate OUTLINE: This is a phase I study . Patients receive porfimer sodium intravenously (IV) over 3-5 minutes and undergo I-PDT approximately 48 hours later. After completion of study treatment, patients are followed up every 1-3 months for the first year, 2-6 months for 2nd year, and annually up to 5 years.
Interventions
BIOLOGICALNivolumab
Immunotherapy - Standard of care
DRUGPorfimer Sodium
Given IV
PROCEDUREInterstitial Illumination Photodynamic Therapy
Undergo I-PDT
OTHERQuality of Life Assessment
Ancillary Studies
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
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Patients with locally advanced or recurrent head and neck cancer who failed to respond to standard therapy and are not amenable to standard curative treatment. * Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician). * 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 the duration of study participation. 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 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
* High dose curative radiotherapy within 30 days in the area to be treated. Tumor invading a major blood vessel. * Tumor is not measurable on a computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Location and extension of the tumor precludes a potentially effective I-PDT. * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds. * Platelet count \< 75,000. * Total serum bilirubin \> 2 mg/dL * Alkaline phosphatase (hepatic) \> 3 times the upper normal limit * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 3 times the upper normal limit * Patients with moderately to severely impaired creatinine clearance (crcl \< 44) will be excluded. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic 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. * Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive porfimer sodium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 30 days | The frequency of toxicities will be tabulated by max grade of any Adverse Events experience by a patient across dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A(Porfimer Sodium, I-PDT Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Nivolumab: Immunotherapy - Standard of care
Porfimer Sodium: Given IV
Interstitial Illumination Photodynamic Therapy: Undergo I-PDT
Quality of Life Assessment: Ancillary Studies | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Arm A(Porfimer Sodium, I-PDT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 11.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 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 | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
The frequency of toxicities will be tabulated by max grade of any Adverse Events experience by a patient across dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.
Time frame: Up to 30 days
Population: All treated and eligible patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A(Porfimer Sodium, I-PDT | Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | grade 3 | 4 Participants |
| Arm A(Porfimer Sodium, I-PDT | Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | grade 1 | 0 Participants |
| Arm A(Porfimer Sodium, I-PDT | Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | grade 2 | 1 Participants |
| Arm A(Porfimer Sodium, I-PDT | Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | grade 4 | 0 Participants |