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

NCT01718223 | Withdrawn DMC

• 2 other identifiers: I 217512NCI-2012-01879
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Up to 6 weeks

Study Arms (1)

Treatment (interstitial photodynamic therapy using temoporfin)

EXPERIMENTAL

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; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Drug: temoporfin

Interventions

photodynamic therapy DRUG

Undergo interstitial photodynamic therapy using temoporfin

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic

Treatment (interstitial photodynamic therapy using temoporfin)

therapeutic conventional surgery PROCEDURE

Undergo surgical resection

Treatment (interstitial photodynamic therapy using temoporfin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (interstitial photodynamic therapy using temoporfin)

temoporfin DRUG

Undergo interstitial photodynamic therapy using temoporfin

Also known as: Foscan, m-tetrahydroxyphenyl-chlorin, mTHPC

Treatment (interstitial photodynamic therapy using temoporfin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Institutes of Health (NIH): collaborator
• Biolitec Pharma Ltd.: collaborator

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; temoporfin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Hassan Arshad, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-09