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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
Biolitec Pharma
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01718223
First received: October 29, 2012
Last updated: February 20, 2014
Last verified: February 2014
  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

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

Resource links provided by NLM:


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: December 2013
Estimated Primary Completion Date: September 2014 (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

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.

  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 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
  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: NCT01718223

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, MD         
Sponsors and Collaborators
Roswell Park Cancer Institute
Biolitec Pharma
Investigators
Principal Investigator: Hassan Arshad, MD 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: February 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tongue Diseases
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
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 July 26, 2014