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Completed

NCT Number: NCT00470496

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

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.

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Key information

Conditions

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Carcinoma Carcinoma, Squamous Cell Cranial Nerve Diseases Endocrine Gland Neoplasms Endocrine System Diseases Esthesioneuroblastoma, Olfactory Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases 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 Diseases 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 Stomatognathic Diseases Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPPH

Drug

Given IV

Other names: Photochlor

photodynamic therapy

Drug

Undergo laser light exposure

Other names: Light Infusion Therapy™, PDT, therapy, photodynamic

conventional surgery

Procedure

Undergo surgery

Other names: surgery, conventional

Primary outcomes

  1. Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity

    Time frame: 30 days

Secondary outcomes

  1. Time to tumor progression or recurrence

    Time frame: From baseline until objective tumor progression, assessed up to 5 years

  2. Uptake and distribution of HPPH in resected tumor tissue

    Time frame: Day 2

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2018
First posted
May 7, 2007
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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