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

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

Recurrent Squamous Cell Carcinoma of the Hypopharynx

Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity

Recurrent Thyroid Cancer

Recurrent Mucoepidermoid Carcinoma of the Oral Cavity

Stage I Papillary Thyroid Cancer

Recurrent Verrucous Carcinoma of the Larynx

Stage II Lymphoepithelioma of the Oropharynx

Stage II Salivary Gland Cancer

Stage II Verrucous Carcinoma of the Oral Cavity

Recurrent Squamous Cell Carcinoma of the Oropharynx

Stage I Follicular Thyroid Cancer

Stage I Squamous Cell Carcinoma of the Hypopharynx

Stage II Squamous Cell Carcinoma of the Larynx

Stage I Inverted Papilloma of the Paranasal Sinus and Nasal Cavity

Stage I Lymphoepithelioma of the Oropharynx

Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage II Inverted Papilloma of the Paranasal Sinus and Nasal Cavity

Stage II Squamous Cell Carcinoma of the Hypopharynx

Stage I Mucoepidermoid Carcinoma of the Oral Cavity

Stage II Mucoepidermoid Carcinoma of the Oral Cavity

Stage I Verrucous Carcinoma of the Oral Cavity

Stage I Adenoid Cystic Carcinoma of the Oral Cavity

Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity

Stage II Adenoid Cystic Carcinoma of the Oral Cavity

Recurrent Lymphoepithelioma of the Nasopharynx

Recurrent Salivary Gland Cancer

Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity

Stage II Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity

Stage I Salivary Gland Cancer

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity

Stage II Basal Cell Carcinoma of the Lip

Stage I Verrucous Carcinoma of the Larynx

Stage II Papillary Thyroid Cancer

Recurrent Basal Cell Carcinoma of the Lip

Stage II Follicular Thyroid Cancer

Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity

Recurrent Verrucous Carcinoma of the Oral Cavity

Recurrent Lymphoepithelioma of the Oropharynx

Stage I Squamous Cell Carcinoma of the Oropharynx

Stage II Lymphoepithelioma of the Nasopharynx

Stage I Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity

Recurrent Squamous Cell Carcinoma of the Larynx

Stage II Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity

Stage I Squamous Cell Carcinoma of the Larynx

Stage II Verrucous Carcinoma of the Larynx

Stage II Squamous Cell Carcinoma of the Oropharynx

Stage I Basal Cell Carcinoma of the Lip

Recurrent Squamous Cell Carcinoma of the Nasopharynx

Recurrent Metastatic Squamous Neck Cancer With Occult Primary

Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Stage I Lymphoepithelioma of the Nasopharynx

Stage I Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity

Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Treatments

Procedure: conventional surgery

Drug: HPPH

Drug: photodynamic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00470496

NCI-2010-01941 (Registry Identifier)

I 74606 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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