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

NCT ID: NCT00470496

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-19
• Study Completion Date: 2018-08-30

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.

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; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Thyroid Cancer; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage I Adenoid Cystic Carcinoma of the Oral Cavity; Stage I Basal Cell Carcinoma of the Lip; Stage I Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity; Stage I Follicular Thyroid Cancer; Stage I Inverted Papilloma of the Paranasal Sinus and Nasal Cavity; Stage I Lymphoepithelioma of the Nasopharynx; Stage I Lymphoepithelioma of the Oropharynx; Stage I Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity; Stage I Mucoepidermoid Carcinoma of the Oral Cavity; Stage I Papillary Thyroid Cancer; Stage I Salivary Gland Cancer; Stage I Squamous Cell Carcinoma of the Hypopharynx; Stage I Squamous Cell Carcinoma of the Larynx; Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage I Squamous Cell Carcinoma of the Oropharynx; Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage I Verrucous Carcinoma of the Larynx; Stage I Verrucous Carcinoma of the Oral Cavity; Stage II Adenoid Cystic Carcinoma of the Oral Cavity; Stage II Basal Cell Carcinoma of the Lip; Stage II Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity; Stage II Follicular Thyroid Cancer; Stage II Inverted Papilloma of the Paranasal Sinus and Nasal Cavity; Stage II Lymphoepithelioma of the Nasopharynx; Stage II Lymphoepithelioma of the Oropharynx; Stage II Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity; Stage II Mucoepidermoid Carcinoma of the Oral Cavity; Stage II Papillary Thyroid Cancer; Stage II Salivary Gland Cancer; Stage II Squamous Cell Carcinoma of the Hypopharynx; Stage II Squamous Cell Carcinoma of the Larynx; Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage II Squamous Cell Carcinoma of the Oropharynx; Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage II Verrucous Carcinoma of the Larynx; Stage II Verrucous Carcinoma of the Oral Cavity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (intraoperative PDT)

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.

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

Given IV

photodynamic therapy

Intervention Type: DRUG

Undergo laser light exposure

conventional surgery

Intervention Type: PROCEDURE

Undergo surgery

Interventions

HPPH

Given IV

Intervention Type: DRUG

photodynamic therapy

Undergo laser light exposure

Intervention Type: DRUG

conventional surgery

Undergo surgery

Intervention Type: PROCEDURE

Other Intervention Names

Photochlor; Light Infusion Therapy™; PDT; therapy, photodynamic; surgery, conventional

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Arshad

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

References

Rigual NR, Shafirstein G, Frustino J, Seshadri M, Cooper M, Wilding G, Sullivan MA, Henderson B. Adjuvant intraoperative photodynamic therapy in head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):706-11. doi: 10.1001/jamaoto.2013.3387.

Reference Type: DERIVED

PMID: 23868427 (View on PubMed)

Other Identifiers

NCI-2010-01941

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 74606

Identifier Type: OTHER

Identifier Source: secondary_id

I 74606

Identifier Type: -

Identifier Source: org_study_id