Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT02068157
First received: February 18, 2014
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Drug: porfimer sodium
Drug: photodynamic therapy
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    A logistic model will be fit to the relationship between the probability of changes in tumor response with intra-tumoral light dose. Wald tests of the model effects will be performed to assess statistical significance at the 0.1 level of significance. A number of diagnostic plots and statistics will be calculated in the evaluation of the model fit.


Secondary Outcome Measures:
  • Serum alkaline DNase (SADA) activity [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.


Estimated Enrollment: 19
Study Start Date: April 2014
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: porfimer sodium
Given IV
Other Names:
  • CL-184116
  • DHE
  • dihematoporphyrin ether
  • Photofrin II
Drug: photodynamic therapy
Undergo image-guided I-PDT
Other Names:
  • Light Infusion Therapy™
  • PDT
  • therapy, photodynamic
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068157

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Hassan Arshad         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Hassan Arshad Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT02068157     History of Changes
Other Study ID Numbers: I 235613, NCI-2014-00210, I 235613, P30CA016056
Study First Received: February 18, 2014
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Head and Neck Neoplasms
Laryngeal Neoplasms
Neoplasms, Unknown Primary
Oropharyngeal Neoplasms
Laryngeal Diseases
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Neoplastic Processes
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pathologic Processes
Pharyngeal Diseases
Pharyngeal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Stomatognathic Diseases
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on November 20, 2014