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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:
ClinicalTrials.gov Identifier:
NCT00470496
First Posted: May 7, 2007
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Time to tumor progression or recurrence [ Time Frame: From baseline until objective tumor progression, assessed up to 5 years ]
  • Uptake and distribution of HPPH in resected tumor tissue [ Time Frame: Day 2 ]

Enrollment: 15
Actual Study Start Date: October 19, 2006
Estimated Study Completion Date: October 1, 2018
Primary Completion Date: October 28, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470496


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

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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 74606 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: May 3, 2007
First Posted: May 7, 2007
Last Update Posted: March 29, 2017
Last Verified: March 2017

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