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

Primary Purpose

Recurrent Head and Neck Carcinoma, Locally Advanced Head and Neck Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nivolumab

Porfimer Sodium

Interstitial Illumination Photodynamic Therapy

Pembrolizumab

Cisplatin

Carboplatin

Cetuximab

Quality of Life Assessment

Fluorouracil

About this trial

This is an interventional treatment trial for Recurrent Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).
Patients are candidates to receive chemotherapy and/or targeted agents, and/or immunotherapy and/or clinically approved treatment for the disease management such as: other chemotherapy, reirradiation or palliative treatment for pain control.
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:

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

Sites / Locations

Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A (standard of care chemotherapy at doctor's discretion)

Arm B(porfimer sodium, I-PDT, SoC chemotherapy)

Arm Description

Patients receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion

Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later. Patients also receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion at either 7 days, 14 days, or 28 days later.

Outcomes

Primary Outcome Measures

Incidence of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I)

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.

Objective target tumor response rates (Phase II)

Will compare locally advanced head and neck cancer (HNC) treated with interstitial photodynamic therapy (I-PDT) followed by standard of care (SoC) to the ones treated with SoC alone. Fisher's exact test will be used for the primary analysis of objective tumor response rates at 10-12 weeks. The primary analysis will be intention-to-treat.

Secondary Outcome Measures

Full Information

NCT ID

NCT03727061

First Posted

October 30, 2018

Last Updated

June 5, 2023

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03727061

Brief Title

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

Official Title

A Randomized, Phase 2 Trial With a Phase 1 Safety Run-in: Porfimer Sodium Mediated Interstitial Photodynamic Therapy and Standard of Care (SoC) Therapy Versus SoC Therapy Alone for the Treatment of Patients With Locally Advanced or Recurrent Head and Neck Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 10, 2019 (Actual)

Primary Completion Date

October 10, 2023 (Anticipated)

Study Completion Date

October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase I/II trial studies the side effects of interstitial photodynamic therapy and to see how well it works with standard of care chemotherapy 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. It is not yet known how well porfimer sodium interstitial photodynamic therapy works, with or without standard of care chemotherapy, in treating patients with head and neck cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the safety of adjuvant porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) who will receive standard of care (SoC) therapy that includes: chemotherapy (cisplatin or carboplatin and fluorouracil [5-FU]) and/or targeted agents (cetuximab), and/or immunotherapy (nivolumab, or pembrolizumab), i.e. standard of care (SoC) therapy and or other clinically approved treatment for the disease management such as: other chemotherapy, reirradiation or palliative treatment for pain control. (Phase I) II. To evaluate the efficacy of adjuvant porfimer sodium mediated I-PDT with SoC therapy by comparing the objective tumor response rate of a locally advanced HNC treated with I-PDT with SoC to SoC therapy alone, in patients with locally advanced or recurrent HNC. (Phase II) EXPLORATORY OBJECTIVES: I. To compare progression free survival (PFS) and overall survival (OS) between adjuvant porfimer sodium mediated I-PDT with SoC therapy and SoC alone, in patients with locally advanced or recurrent HNC. (Phase II) II. To compare changes in quality of life (QoL) between adjuvant porfimer sodium mediated I-PDT with SoC therapy and SoC alone, in patients with locally advanced or recurrent HNC. (Phase II) III. To evaluate the relationship between response rate and immune markers in patients with locally advanced or recurrent HNC receiving either adjuvant porfimer sodium mediated I-PDT with SoC therapy or SoC alone. (Phase II) IV. To evaluate the relationship between objective response rate and levels of serum alkaline deoxyribonuclease (DNase) activity (SADA), a circulating biomarker, in patients with locally advanced or recurrent HNC receiving either adjuvant porfimer sodium mediated I-PDT with SoC therapy or SoC alone. (Phase II) OUTLINE: This is a phase I study followed by a phase II study. PHASE I: Patients receive porfimer sodium intravenously (IV) over 3-5 minutes and undergo I-PDT approximately 48 hours later. Patients also receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion at either 7 days, 14 days, or 28 days later. PHASE II: Patients are randomized to 1 of 2 arms. ARM A: Patients receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion. ARM B: Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later. Patients also receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion at either 7 days, 14 days, or 28 days later. After completion of study treatment, patients are followed up at 30 days, 1-3 months for 1 year, 2-6 months for 1 year, and annually up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Head and Neck Carcinoma, Locally Advanced Head and Neck Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A (standard of care chemotherapy at doctor's discretion)

Arm Type

Active Comparator

Arm Description

Patients receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion

Arm Title

Arm B(porfimer sodium, I-PDT, SoC chemotherapy)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

NIVO, NIVOLUMAB, Nivolumab, BMS-936558

Intervention Description

Immunotherapy - Standard of care

Intervention Type

Drug

Intervention Name(s)

Porfimer Sodium

Other Intervention Name(s)

Photofrin II, Photofrin II, PORFIMER SODIUM, porfimer sodium, Porfimer Sodium

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Interstitial Illumination Photodynamic Therapy

Intervention Description

Undergo I-PDT

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Intervention Description

Immunotherapy - Standard of care

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol

Intervention Description

Standard of Care

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino,

Intervention Description

Standard of Care

Intervention Type

Biological

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Cetuximab Biosimilar CMAB009,

Intervention Description

Standard of Care

Intervention Type

Other

Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary Studies

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Other Intervention Name(s)

5-Fluorouracil, 5-Fluracil, 5-FU

Intervention Description

Standard of Care

Primary Outcome Measure Information:

Title

Incidence of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I)

Description

Time Frame

Up to 30 days

Title

Objective target tumor response rates (Phase II)

Description

Time Frame

At 10-12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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). Patients are candidates to receive chemotherapy and/or targeted agents, and/or immunotherapy and/or clinically approved treatment for the disease management such as: other chemotherapy, reirradiation or palliative treatment for pain control. 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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kimberly Wooten, MD

Phone

716-845-4094

Kimberly.Wooten@roswellpark.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberly Wooten, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ASK RPCI

Phone

877-275-7724

ASKRPCI@RoswellPark.org

12. IPD Sharing Statement

Learn more about this trial

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

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