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
18 Years
N/A
Both
Head and Neck Cancer
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 Institute | Tampa, Florida 33612 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Division of Head and Neck Surgery | Evanston, Illinois 60201 |
| Norton Healthcare Pavilion | Louisville, Kentucky 40202 |
| Ear, Nose, and Throat Specialty Care of Minnesota, P.A. | Minneapolis, Minnesota 55404 |
| School of Dental Medicine | Buffalo, New York 14214-3008 |
| St. Luke's-Roosevelt Hospital | New York, New York 10019 |
