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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:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00470496
First received: May 3, 2007
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

RATIONALE: Photodynamic therapy 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.

PURPOSE: This phase I trial is studying 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.


Condition Intervention Phase
Head and Neck Cancer
 Drug: HPPH
Procedure: therapeutic conventional surgery
 Phase 1

Study Type: Interventional
Study Design: 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:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Maximum tolerated dose of photodynamic therapy [ Time Frame: Within 24 hours of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor progression or recurrence [ Time Frame: At 1 month and 3 months ] [ Designated as safety issue: No ]
  • HPPH uptake and distribution [ Time Frame: At 1 and 3 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2006
Estimated Study Completion Date: July 2014
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: HPPH
    Given IV
    Procedure: therapeutic conventional surgery
    Tumor removal
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of photodynamic therapy comprising HPPH in patients undergoing surgery for primary or recurrent squamous cell cancer of the head and neck.

Secondary

  • Determine the efficacy of this regimen, in terms of tumor recurrence rate, in these patients.
  • Determine HPPH uptake and distribution in these patients.
  • Observe for wound complications in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of laser light.

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.

Cohorts of 3-6 patients receive escalating doses of laser light until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 1 month, every 3 months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell cancer of the head and neck

    • Primary or recurrent disease
    • Operable disease that can be removed surgically within the expectation of clear margins without compromising vital structures
  • Planning to undergo surgery to remove the cancer

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • WBC ≥ 4,000/mm³
  • Platelet count ≥ 100,000/mm³
  • PTT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.0 mg/dL
  • Creatinine ≤ 2.0 mg/dL
  • Alkaline phosphatase ≤ 3 times ULN
  • ALT ≤ 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3-6 months after completion of study therapy
  • No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy
  • At least 30 days since prior radiotherapy, chemotherapy, or other biologic therapy
  • No concurrent chemotherapy or radiotherapy
  Contacts and Locations
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, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Nestor R. Rigual, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470496     History of Changes
Other Study ID Numbers: I 74606, RPCI-I-74606
Study First Received: May 3, 2007
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
 recurrent squamous cell carcinoma of the nasopharynx
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
salivary gland squamous cell carcinoma
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
recurrent salivary gland cancer
stage IV salivary gland cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013