NCT03090412

Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer

A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery in treating patients with oral cavity cancer.

Detailed description

PRIMARY OBJECTIVES: I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery by comparing the rate of tumor response after PDT to those observed after surgery, at 24 months post treatment. SECONDARY OBJECTIVES: I. To determine quality of life (QoL) at 6, 12, 18 and 24 months post PDT or surgery. II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0). TERTIARY OBJECTIVES: I. Immune markers (T cells). II. To investigate the correlation of the diffuse reflectance optical spectroscopy with tumor response to PDT. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo standard of care surgery on day 1. ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0 and undergo PDT on day 1. After completion of study treatment, patients are followed up every 3-4 months in year 1 and every 3-6 months in year 2.

Conditions

• Stage I Oral Cavity Squamous Cell Carcinoma
• Stage II Oral Cavity Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HPPH	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Photodynamic Therapy	Undergo PDT
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo standard of care surgery

Timeline

• Start date: 2018-03-07
• Primary completion: 2021-08-01
• Completion: 2021-08-06
• First posted: 2017-03-24
• Last updated: 2022-06-02
• Results posted: 2022-06-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study