NCT02068157

Brief Summary

This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2016

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 28, 2017

Completed
Last Updated

October 11, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

February 18, 2014

Results QC Date

July 26, 2017

Last Update Submit

September 11, 2017

Conditions

Recurrent Laryngeal Squamous Cell CarcinomaRecurrent Laryngeal Verrucous CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult PrimaryRecurrent Oral Cavity Verrucous CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaTongue Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1

    Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Up to 12 months

Secondary Outcomes (1)

  • Serum Alkaline DNase (SADA) Activity

    Up to 12 months

Study Arms (1)

Treatment (porfimer sodium, image-guided I-PDT)

EXPERIMENTAL

Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.

Other: Laboratory Biomarker AnalysisDrug: Photodynamic TherapyDrug: Porfimer Sodium

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (porfimer sodium, image-guided I-PDT)
Photodynamic TherapyDRUG

Undergo image-guided I-PDT

Also known as: PDT, Photoradiation Therapy
Treatment (porfimer sodium, image-guided I-PDT)
Porfimer SodiumDRUG

Given IV

Also known as: CL-184116, DHE, Dihematoporphyrin Ester, Dihematoporphyrin Ether, Photofrin II
Treatment (porfimer sodium, image-guided I-PDT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
  • Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck
  • Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
  • Patients on chemotherapy \&/or targeted agents for palliation
  • 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 6 months after the last treatment; 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

You may not qualify if:

  • Radiotherapy within the last 2 months in the area to be treated
  • Patients with known brain metastases should be excluded from this clinical trial
  • Tumor invading a major blood vessel (such as the carotid artery)
  • Tumor is not clearly shown on a computed tomography (CT) scan
  • Location and extension of the tumor precludes an effective I-PDT
  • Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
  • While blood cell (WBC) \< 2.0 x 10\^9/L
  • Total serum bilirubin \> 2.0 mg/dl
  • Serum creatinine \> 2 mg/dl
  • Alkaline phosphatase (hepatic) \> 3 times the upper normal limit
  • Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper limit of normal
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, acute exacerbation of 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 and the light exposure precautions
  • Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckLymphoid Interstitial PneumoniaTongue Neoplasms

Interventions

Photochemotherapy1-phenyl-3,3-dimethyltriazenePhototherapyDihematoporphyrin EtherTrioxsalen

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth NeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyHematoporphyrin DerivativeHematoporphyrinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological FactorsFurocoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, 3-Ring

Results Point of Contact

Title
Senior Administrator, Compliance - Clinical Research Services
Organization
Roswell Park Cancer Institute
Adrienne.Groman@RoswellPark.org
716-845-2300

Study Officials

  • Hassan Arshad

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 21, 2014

Study Start

April 1, 2014

Primary Completion

October 13, 2016

Study Completion

November 4, 2016

Last Updated

October 11, 2017

Results First Posted

August 28, 2017

Record last verified: 2017-09

Locations

US(1)