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

Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Clinical Trial

Official title:

A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470496
• Other study ID #: I 74606
• Secondary ID: NCI-2010-01941I
• Status: Completed
• Phase: Phase 1
• Start date: October 19, 2006
• Est. completion date: August 30, 2018

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 30, 2018
• Est. primary completion date: October 28, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenoid Cystic
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Esthesioneuroblastoma, Olfactory
• Granuloma
• Head and Neck Neoplasms
• Laryngeal Diseases
• Laryngeal Neoplasms
• Nasopharyngeal Carcinoma
• Oropharyngeal Neoplasms
• Papilloma
• Paranasal Sinus Neoplasms
• Recurrence
• 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
• Salivary Gland Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• 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
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• HPPH
Given IV
• photodynamic therapy
Undergo laser light exposure

Procedure:
• conventional surgery
Undergo surgery

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity		30 days
Secondary	Time to tumor progression or recurrence		From baseline until objective tumor progression, assessed up to 5 years
Secondary	Uptake and distribution of HPPH in resected tumor tissue		Day 2