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

This study has been withdrawn prior to enrollment.
(implementation issues)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718223
First Posted: October 31, 2012
Last Update Posted: September 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Biolitec Pharma Ltd.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
  • Ratio of the viable/nonviable tissue in the resected tumor, ex vivo [ Time Frame: Up to 6 weeks ]
    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.


Enrollment: 0
Study Start Date: December 2013
Study Completion Date: August 2014
Primary Completion Date: August 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718223


Sponsors and Collaborators
Roswell Park Cancer Institute
National Institutes of Health (NIH)
Biolitec Pharma Ltd.
Investigators
Principal Investigator: Hassan Arshad, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01718223     History of Changes
Other Study ID Numbers: I 217512
NCI-2012-01879 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 29, 2012
First Posted: October 31, 2012
Last Update Posted: September 3, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Mouth Diseases
Tongue Diseases
Temoporfin
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents