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A Multicenter, Multi-National, Open-Label, Single Group, Single and Multiple Dose Study of Foscan-Mediated Photodynamic Therapy (PDT) for the Palliative Treatment of Recurrent, Refractory or Second Primary Squamous Cell Carcinomas of the Head and Neck in Patients Considered to be Incurable With Surgery or Radiotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A Multicenter, Multi-National, Open-Label, Single Group, Single and Multiple Dose Study of Foscan-Mediated Photodynamic Therapy (PDT) for the Palliative Treatment of Recurrent, Refractory or Second Primary Squamous Cell Carcinomas of the Head and Neck in Patients Considered to be Incurable With Surgery or Radiotherapy


OBJECTIVES: I. Determine the individual clinical benefit of temoporfin-mediated photodynamic
therapy for palliative treatment in patients with recurrent, refractory, or second primary
squamous cell cancer of the head and neck. II. Determine the improvement in global,
functional, and symptomatic measures of quality of life in these patients. III. Determine
the toxic effects, tolerability, and safety of this regimen in these patients. IV. Determine
the population pharmacokinetics, objective tumor response (complete and partial), and the 1
year survival of these patients on this regimen.

OUTLINE: This is a multicenter study. Patients receive IV temoporfin on day -4, followed by
laser light therapy on day 0. Patients are treated every 4 to 16 weeks for a maximum of 3
courses. Patients are evaluated on days 1, 2, 7, and weeks 2, 4, 6, 8, 12, and 16 following
laser light therapy. Quality of life is assessed at baseline through week 12 of follow-up.
Patients are followed monthly for 4 months after the final treatment, then every 3 months
for 1 year.

PROJECTED ACCRUAL: A minimum of 50 prospective and 25 retrospective patients will be accrued
for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed recurrent, refractory, or second primary
squamous cell cancer of the head and neck that is incurable with surgery or radiotherapy
Any N, Any M, single or multiple tumor(s) Locally accessible, discrete tumor(s) by CT or
MRI scan Must be considered incurable with surgery or radiotherapy, for example: Distant
disease (e.g., lung and/or liver metastases) OR Cervical disease fixed to surrounding
structures (e.g., carotid artery or prevertebral fascia) OR Metastases in the site of
prior radiotherapy OR Not suitable for anesthesia or reconstructive surgery OR Multiple
cutaneous metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No disease exacerbated by light, including systemic lupus erythematosus,
psoriasis, porphyria, actinic reticuloid, or xeroderma pigmentosum Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 30 days
since prior chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: Concurrent
steroid therapy allowed Radiotherapy: At least 30 days since prior radiotherapy to the
head and neck Surgery: At least 30 days since prior surgery and recovered Other: At least
30 days since prior light activated therapy or medication (e.g.,PUVA or Accutane) No prior
photodynamic therapy At least 30 days since prior experimental drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Barbara Larson

Investigator Role:

Study Chair

Investigator Affiliation:

Quintiles

Authority:

United States: Federal Government

Study ID:

CDR0000067019

NCT ID:

NCT00003856

Start Date:

October 1998

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent salivary gland cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Division of Head and Neck SurgeryEvanston, Illinois  60201
Norton Healthcare PavilionLouisville, Kentucky  40202
Ear, Nose, and Throat Specialty Care of Minnesota, P.A.Minneapolis, Minnesota  55404
School of Dental MedicineBuffalo, New York  14214-3008
St. Luke's-Roosevelt HospitalNew York, New York  10019