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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of photodynamic therapy

Outcome Time Frame:

Within 24 hours of treatment

Safety Issue:

Yes

Principal Investigator

Nestor R. Rigual, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 74606

NCT ID:

NCT00470496

Start Date:

October 2006

Completion Date:

July 2014

Related Keywords:

  • Head and Neck Cancer
  • 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
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Head and Neck Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263