Spots Global Cancer Trial Database for Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer

Study Description

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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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