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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00470496
First received: May 3, 2007
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
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
Drug: HPPH
Drug: photodynamic therapy
Procedure: conventional surgery
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to tumor progression or recurrence [ Time Frame: From baseline until objective tumor progression, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Uptake and distribution of HPPH in resected tumor tissue [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2006
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: HPPH
Given IV
Other Name: Photochlor
Drug: photodynamic therapy
Undergo laser light exposure
Other Names:
  • Light Infusion Therapy™
  • PDT
  • therapy, photodynamic
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470496

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Hassan Arshad Roswell Park Cancer Institute
  More Information

No publications provided by Roswell Park Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470496     History of Changes
Other Study ID Numbers: I 74606, NCI-2010-01941, I 74606, P30CA016056
Study First Received: May 3, 2007
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Carcinoma, Adenoid Cystic
Granuloma
Head and Neck Neoplasms
Laryngeal Diseases
Papilloma
Thyroid Diseases
Adenocarcinoma, Follicular
Carcinoma, Mucoepidermoid
Carcinoma, Verrucous
Esthesioneuroblastoma, Olfactory
Papilloma, Inverted
Neoplasms, Unknown Primary
Salivary Gland Neoplasms
Laryngeal Neoplasms
Paranasal Sinus Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Endocrine System Diseases
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Adenocarcinoma

ClinicalTrials.gov processed this record on August 20, 2014