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Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer

Primary Purpose

Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Photodynamic Therapy
Porfimer Sodium
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Laryngeal Squamous Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum Alkaline DNase (SADA) Activity
SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.

Full Information

First Posted
February 18, 2014
Last Updated
September 11, 2017
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02068157
Brief Title
Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
Official Title
Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Study no longer has an active IDE
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
October 13, 2016 (Actual)
Study Completion Date
November 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients. OUTLINE: Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (porfimer sodium, image-guided I-PDT)
Arm Type
Experimental
Arm Description
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Photodynamic Therapy
Other Intervention Name(s)
PDT, Photoradiation Therapy
Intervention Description
Undergo image-guided I-PDT
Intervention Type
Drug
Intervention Name(s)
Porfimer Sodium
Other Intervention Name(s)
CL-184116, DHE, Dihematoporphyrin Ester, Dihematoporphyrin Ether, Photofrin II
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Serum Alkaline DNase (SADA) Activity
Description
SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Arshad
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
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer

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