Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment of Patients With Locally Advanced or Recurrent Head and Neck Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Head and Neck Carcinoma; Locally Advanced Head and Neck Carcinoma
• Intervention / Treatment: Drug: Porfimer Sodium; Biological: Nivolumab; Other: Quality of Life Assessment; Procedure: Interstitial Illumination Photodynamic Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kimberly Wooten, MD; Phone Number: 716-845-4094; Email: Kimberly.Wooten@roswellpark.org

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263-0001
      • Recruiting
      • Roswell Park Cancer Institute
      • Contact: ASK RPCI; Phone Number: 877-275-7724; Email: ASKRPCI@RoswellPark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A(porfimer sodium, I-PDT; Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.	Drug: Porfimer Sodium; Given IV; Other Names: Photofrin II, Photofrin II, PORFIMER SODIUM, porfimer sodium, Porfimer Sodium; Biological: Nivolumab; Immunotherapy - Standard of care; Other Names: NIVO, NIVOLUMAB, Nivolumab, BMS-936558; Other: Quality of Life Assessment; Ancillary Studies; Procedure: Interstitial Illumination Photodynamic Therapy; Undergo I-PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kimberly Wooten, MD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Head and Neck Neoplasms; Carcinoma; Recurrence; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Photosensitizing Agents; Dermatologic Agents; Immune Checkpoint Inhibitors; Nivolumab; Dihematoporphyrin Ether; Trioxsalen; Hematoporphyrin Derivative
• Other Study ID Numbers: I 67918; R01CA193610 (U.S. NIH Grant/Contract); P01CA055791 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes