Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer

Phase 1

Completed

• Conditions: Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Recurrent Basal Cell Carcinoma of the Lip; Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity; Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity; Recurrent Lymphoepithelioma of the Nasopharynx; Recurrent Lymphoepithelioma of the Oropharynx; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity; Recurrent Mucoepidermoid Carcinoma of the Oral Cavity; Recurrent Salivary Gland Cancer
• Interventions: Drug: HPPH; Drug: photodynamic therapy; Procedure: conventional surgery

• Registration Number: NCT00470496
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.

Detailed Description

PRIMARY OBJECTIVES:

I. Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers.

SECONDARY OBJECTIVES:

I. To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients.

II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens.

III. Observe for wound complications.

OUTLINE: This is a dose-escalation study of laser light.

Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.

After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician.

Study Timeline

• Study Start: 2006-10-19
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-07
• Primary Completion: 2011-10-28
• Study Completion: 2018-08-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator)
• Female patients must not be pregnant (documented by human chorionic gonadotropin [HCG] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
• No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT

Exclusion Criteria

• Patients with unresectable tumors
• Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
• White blood cell (WBC) < 4,000
• Platelet count < 100,000
• Prothrombin time 1.5 times above the upper normal limit
• Total serum bilirubin > 2.0 mg/d
• Serum creatinine > 2 mg%
• Alkaline phosphatase (hepatic) > 3 times the upper normal limit
• Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
• Patients on concurrent chemotherapy or radiation therapy will be excluded
• Patients who have received radiation therapy, chemotherapy or other biological therapy during the past 30 days
• Has not recovered from toxicity of prior therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (intraoperative PDT)	photodynamic therapy	Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
Treatment (intraoperative PDT)	conventional surgery	Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
Treatment (intraoperative PDT)	HPPH	Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity	30 days

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression or recurrence	From baseline until objective tumor progression, assessed up to 5 years
Uptake and distribution of HPPH in resected tumor tissue	Day 2

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States