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

Phase 2

Terminated

Conditions: Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Verrucous Carcinoma
Recurrent Laryngeal Verrucous Carcinoma
Tongue Carcinoma

Interventions: Other: Laboratory Biomarker Analysis
Drug: Photodynamic Therapy
Drug: Porfimer Sodium

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Treatment (porfimer sodium, image-guided I-PDT)	Laboratory Biomarker Analysis	Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Treatment (porfimer sodium, image-guided I-PDT)	Photodynamic Therapy	Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Treatment (porfimer sodium, image-guided I-PDT)	Porfimer Sodium	Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1	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

Name	Time	Method
Serum Alkaline DNase (SADA) Activity	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.