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

Recurrent Laryngeal Squamous Cell Carcinoma Clinical Trial

Official title:

Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02068157
• Other study ID #: I 235613
• Secondary ID: NCI-2014-00210I
• Status: Terminated
• Phase: Phase 2
• First received: February 18, 2014
• Last updated: September 11, 2017
• Start date: April 1, 2014
• Est. completion date: November 4, 2016

Study information

• Verified date: September 2017
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 4, 2016
• Est. primary completion date: October 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• 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

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Drug:
• Photodynamic Therapy
Undergo image-guided I-PDT
• Porfimer Sodium
Given IV

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 12 months