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

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ClinicalTrials.gov Identifier: NCT02068157
Recruitment Status : Terminated (Study no longer has an active IDE)
First Posted : February 21, 2014
Results First Posted : August 28, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
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 Other: Laboratory Biomarker Analysis Drug: Photodynamic Therapy Drug: Porfimer Sodium Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II
Actual Study Start Date : April 1, 2014
Primary Completion Date : October 13, 2016
Study Completion Date : November 4, 2016


Arm Intervention/treatment
Experimental: Treatment (porfimer sodium, image-guided I-PDT)
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 Analysis
Correlative studies
Drug: Photodynamic Therapy
Undergo image-guided I-PDT
Other Names:
  • PDT
  • Photoradiation Therapy
Drug: Porfimer Sodium
Given IV
Other Names:
  • CL-184116
  • DHE
  • Dihematoporphyrin Ester
  • Dihematoporphyrin Ether
  • Photofrin II



Primary Outcome Measures :
  1. Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1 [ Time Frame: Up to 12 months ]
    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 :
  1. Serum Alkaline DNase (SADA) Activity [ Time Frame: Up to 12 months ]
    SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.



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

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): NCT02068157


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Hassan Arshad Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT02068157     History of Changes
Other Study ID Numbers: I 235613
NCI-2014-00210 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 235613 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2014    Key Record Dates
Results First Posted: August 28, 2017
Last Update Posted: October 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents