Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer

A Pilot Study of Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity

This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Study Overview

• Status: Withdrawn
• Conditions: Tongue Cancer; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage I Squamous Cell Carcinoma of the Oropharynx; Stage I Verrucous Carcinoma of the Oral Cavity; Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage II Squamous Cell Carcinoma of the Oropharynx; Stage II Verrucous Carcinoma of the Oral Cavity
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery; Drug: photodynamic therapy; Drug: temoporfin

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).

SECONDARY OBJECTIVES:

I. Quantify the relationship between the measured intra-tumor light dose and the pathological tumor response.

TERTIARY OBJECTIVES:

I. Simulate light dose distribution within the treated tumor. II. Immune markers.

OUTLINE:

Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.

After completion of study treatment, patients are followed for 3 years.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery
• Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
• Life expectancy of at least 6 months in the judgment of the physician
• Blood urea nitrogen (BUN) =< upper limit of normal (ULN)
• White blood count > 3,000 per microliter or
• Absolute neutrophil count (ANC) > 1500 per microliter
• Serum calcium within normal limits; note: serum calcium will be corrected for low albumin, if necessary
• 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 the duration of study participation; 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:

• Subjects who have had radiotherapy within the last 3 months
• Subjects with known brain metastases should be excluded from this clinical trial
• Tumor invading a major blood vessel (such as the carotid artery)
• Tumor invading the skull base
• Subjects with ophthalmic disease
• Tumor is not clearly shown on an imaging scan/location and extension of tumor that precludes effective PDT, in the judgment of the primary investigator (PI)
• Location and extension of the tumor precludes an effective interstitial photodynamic therapy (iPDT)
• Patients with known hypersensitivity to porphyrins or with porphyria
• Has distant metastasis that decreases life expectancy to less than 6 months
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic 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 investigator's opinion deems the subject an unsuitable candidate to receive study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (interstitial photodynamic therapy using temoporfin); Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.

Other: laboratory biomarker analysis; Correlative studies; Procedure: therapeutic conventional surgery; Undergo surgical resection; Drug: photodynamic therapy; Undergo interstitial photodynamic therapy using temoporfin; Other Names: PDT; Light Infusion Therapy™; therapy, photodynamic; Drug: temoporfin; Undergo interstitial photodynamic therapy using temoporfin; Other Names: Foscan; m-tetrahydroxyphenyl-chlorin; mTHPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events, graded according to NCI CTCAE version 4.0	The frequency of toxicities will be tabulated by grade.	Up to 30 days after surgical resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system		Day 3
Ratio of the viable/nonviable tissue in the resected tumor, ex vivo	The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Institutes of Health (NIH); Biolitec Pharma Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: September 2, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Neoplasms, Squamous Cell; Mouth Neoplasms; Tongue Diseases; Carcinoma; Recurrence; Carcinoma, Squamous Cell; Oropharyngeal Neoplasms; Carcinoma, Verrucous; Tongue Neoplasms; Antineoplastic Agents; Photosensitizing Agents; Dermatologic Agents; Temoporfin
• Other Study ID Numbers: I 217512; NCI-2012-01879 (Registry Identifier: CTRP (Clinical Trial Reporting Program))