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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03727061
Other study ID # I 67918
Secondary ID R01CA193610P01CA
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 10, 2019
Est. completion date December 10, 2024

Study information

Verified date March 2024
Source Roswell Park Cancer Institute
Contact Kimberly Wooten, MD
Phone 716-845-4094
Email Kimberly.Wooten@roswellpark.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 10, 2024
Est. primary completion date December 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Nivolumab
Immunotherapy - Standard of care
Drug:
Porfimer Sodium
Given IV
Procedure:
Interstitial Illumination Photodynamic Therapy
Undergo I-PDT
Other:
Quality of Life Assessment
Ancillary Studies

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence 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 grade across all dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity. Sequential boundaries will be used to monitor the serious adverse event (SAE) rate. Up to 30 days
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