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

Purpose

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.

Condition	Intervention
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 Tongue Cancer	Drug: photodynamic therapy Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis Drug: temoporfin

Condition

Intervention

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
Tongue Cancer

Drug: photodynamic therapy
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Drug: temoporfin

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Frequency of adverse events, graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after surgical resection ] [ Designated as safety issue: Yes ]
The frequency of toxicities will be tabulated by grade.

Secondary Outcome Measures:

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 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Ratio of the viable/nonviable tissue in the resected tumor, ex vivo [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	5
Study Start Date:	May 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

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.

Drug: photodynamic therapy

Undergo interstitial photodynamic therapy using temoporfin

Other Names:

Light Infusion Therapy™
PDT
therapy, photodynamic

Procedure: therapeutic conventional surgery

Undergo surgical resection

Other: laboratory biomarker analysis

Correlative studies

Drug: temoporfin

Undergo interstitial photodynamic therapy using temoporfin

Other Names:

Foscan
m-tetrahydroxyphenyl-chlorin
mTHPC

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. III. Circulating endothelial cells.

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 up at 30 days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Histologically confirmed recurrent 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718223

Locations

United States, New York
Roswell Park Cancer Institute	Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org
Principal Investigator: Nestor R. Rigual

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Nestor Rigual

Roswell Park Cancer Institute

More Information

No publications provided

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT01718223 History of Changes
Other Study ID Numbers:	I 217512, NCI-2012-01879
Study First Received:	October 29, 2012
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Tongue Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

Tongue Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Temoporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013