NCT01718223

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

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

Interventions

Type	Name	Description
DRUG	photodynamic therapy	Undergo interstitial photodynamic therapy using temoporfin
PROCEDURE	therapeutic conventional surgery	Undergo surgical resection
OTHER	laboratory biomarker analysis	Correlative studies
DRUG	temoporfin	Undergo interstitial photodynamic therapy using temoporfin

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-10-31
• Last updated: 2014-09-03