RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be an effective palliative treatment for head and neck cancer. PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy for palliative treatment in patients who have recurrent, refractory, or second primary head and neck cancer that cannot be treated with surgery or radiation therapy.

Condition	Treatment or Intervention	Phase
recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the hypopharynx recurrent salivary gland cancer recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity Quality of Life	Drug: temoporfin	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

Barbara Larson,  Study Chair,  Quintiles   

Study ID Numbers:  CDR0000067019; QUINT-009.003.08b; NCI-V99-1539; SCOTIA-QUINT-009.003.08b
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003856
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08