Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy
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.
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.
Primary Purpose: Treatment
Head and Neck Cancer
University of Arkansas for Medical Sciences
Active, not recruiting
National Cancer Institute (NCI)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00003856
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Head And Neck Neoplasms
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.
A form of RHABDOMYOSARCOMA arising primarily in the head and neck, especially the orbit, of children below the age of 10. The cells are smaller than those of other rhabdomyosarcomas and are of two basic cell types: spindle cells and round cells. This cancer is highly sensitive to chemotherapy and has a high cure rate with multi-modality therapy. (From Holland et al., Cancer Medicine, 3d ed, p2188)
A symptom, not a disease, of a twisted neck. In most instances, the head is tipped toward one side and the chin rotated toward the other. The involuntary muscle contractions in the neck region of patients with torticollis can be due to congenital defects, trauma, inflammation, tumors, and neurological or other factors.
Large veins on either side of the root of the neck formed by the junction of the internal jugular and subclavian veins. They drain blood from the head, neck, and upper extremities, and unite to form the superior vena cava.
Through this study, we hope to learn more about the mechanisms, which may contribute to development and progression of head and neck cancer. The long-term goal of this study will be to de...
The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient
The purpose of this study is to determine the effectiveness and side effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer. Patients with...
Patients with head and neck cancer will be imaged with PET scan and CT scan in order to determine areas of the tumour that are hypoxic. It is hypothesized that PET /CT will provide inform...
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer....
Scientific innovation has enabled whole exome capture and massively parallel sequencing of cancer genomes. In head and neck cancer, next-generation sequencing has granted us further understanding of t...
BACKGROUND: Head and neck cancer is a common second cancer in patients with a history of hematological malignancies. The purpose of this study was present the clinical characteristics and treatment ou...
BACKGROUND: Estimation of attributable fractions for tobacco and alcohol, and investigation of the association between body mass index (BMI) and head and neck cancer risk have largely been in case-con...
BACKGROUND: Posttreatment speech problems are seen in nearly half of patients with head and neck cancer. Although there are many voice-specific scales, surprisingly there is no speech-specific questio...