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

NCT03727061 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: I 67918R01CA193610P01CA055791
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Head and Neck Carcinoma; Locally Advanced Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 days

Study Arms (1)

Arm A(porfimer sodium, I-PDT

EXPERIMENTAL

Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.

Biological: Nivolumab; Drug: Porfimer Sodium; Procedure: Interstitial Illumination Photodynamic Therapy; Other: Quality of Life Assessment

Interventions

Nivolumab BIOLOGICAL

Immunotherapy - Standard of care

Also known as: NIVO, NIVOLUMAB, Nivolumab, BMS-936558

Arm A(porfimer sodium, I-PDT

Porfimer Sodium DRUG

Given IV

Also known as: Photofrin II, Photofrin II, PORFIMER SODIUM, porfimer sodium, Porfimer Sodium

Arm A(porfimer sodium, I-PDT

Interstitial Illumination Photodynamic Therapy PROCEDURE

Undergo I-PDT

Arm A(porfimer sodium, I-PDT

Quality of Life Assessment OTHER

Ancillary Studies

Arm A(porfimer sodium, I-PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Interventions

Nivolumab; Dihematoporphyrin Ether

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Compressive Cancer Center

adrienne.groman@roswellpark.org

716-845-2300

Study Officials

• Kimberly Wooten, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: July 10, 2019
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-01

Locations

US (1)