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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

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ClinicalTrials.gov Identifier: NCT03727061
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Recurrent Head and Neck Carcinoma Locally Advanced Head and Neck Carcinoma Biological: Nivolumab Drug: Porfimer Sodium Procedure: Interstitial Illumination Photodynamic Therapy Biological: Pembrolizumab Drug: Cisplatin Drug: Carboplatin Biological: Cetuximab Other: Quality of Life Assessment Drug: Fluorouracil Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center 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
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A (standard of care chemotherapy at doctor's discretion)
Patients receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion
Biological: Nivolumab
Immunotherapy - Standard of care
Other Name: NIVO, NIVOLUMAB, Nivolumab, BMS-936558

Biological: Pembrolizumab
Immunotherapy - Standard of care

Drug: Cisplatin
Standard of Care
Other Name: Platinol

Drug: Carboplatin
Standard of Care
Other Name: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino,

Biological: Cetuximab
Standard of Care
Other Name: Cetuximab Biosimilar CMAB009,

Other: Quality of Life Assessment
Ancillary Studies

Drug: Fluorouracil
Standard of Care
Other Name: 5-Fluorouracil, 5-Fluracil, 5-FU

Experimental: Arm B(porfimer sodium, I-PDT, SoC chemotherapy)
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.
Biological: Nivolumab
Immunotherapy - Standard of care
Other Name: NIVO, NIVOLUMAB, Nivolumab, BMS-936558

Drug: Porfimer Sodium
Given IV
Other Name: Photofrin II, Photofrin II, PORFIMER SODIUM, porfimer sodium, Porfimer Sodium

Procedure: Interstitial Illumination Photodynamic Therapy
Undergo I-PDT

Biological: Pembrolizumab
Immunotherapy - Standard of care

Drug: Cisplatin
Standard of Care
Other Name: Platinol

Drug: Carboplatin
Standard of Care
Other Name: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino,

Biological: Cetuximab
Standard of Care
Other Name: Cetuximab Biosimilar CMAB009,

Other: Quality of Life Assessment
Ancillary Studies

Drug: Fluorouracil
Standard of Care
Other Name: 5-Fluorouracil, 5-Fluracil, 5-FU




Primary Outcome Measures :
  1. Incidence of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I) [ Time Frame: Up to 30 days ]
    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.

  2. Objective target tumor response rates (Phase II) [ Time Frame: At 10-12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale 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 or legal representative 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727061


Contacts
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Contact: Hassan Arshad, MD 716-845-8215 Hassan.Arshad@roswellpark.org

Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: ASK RPCI    877-275-7724    ASKRPCI@RoswellPark.org   
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Hassan Arshad, MD Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03727061     History of Changes
Other Study ID Numbers: I 67918
R01CA193610 ( U.S. NIH Grant/Contract )
P30CA016056 ( U.S. NIH Grant/Contract )
P01CA055791 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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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
Additional relevant MeSH terms:
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Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Cisplatin
Carboplatin
Nivolumab
Pembrolizumab
Fluorouracil
Cetuximab
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Antineoplastic Agents, Immunological
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents