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Phase I Study of Porfiromycin and Radiotherapy in Patients with Head and Neck Cancer (Summary Last Modified 02/91)
Basic Trial Information
Objectives I. Determine a safe dose and the acute effects on normal tissue of porfiromycin when given as an adjuvant to radiotherapy in the treatment of epidermoid carcinoma of the head and neck. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients 20 to 80 years of age with biopsy-proven epidermoid carcinoma of the head and neck limited to the oral cavity, pharynx, or larynx (as defined by the AJCC). The presence of distant metastases excludes. Newly diagnosed patients must present with AJCC Stage IV disease deemed incurable by surgery and/or radiotherapy (less than 15% 5-year survival) by the Joint Head and Neck Tumor Board of the Yale Comprehensive Cancer Center; those with advanced neck disease from an unknown primary are also eligible. Patients with recurrent disease who have previously undergone surgery for any stage head and neck cancer are also eligible. Patients must be receiving external beam radiotherapy or external beam radiotherapy with brachytherapy for their disease. Surgery prior to radiotherapy is allowed, but there may have been no prior radiotherapy within the proposed treatment site and no chemotherapy during the 3 years prior to entry. An ECOG performance status of 2 or better and a life expectancy of at least 6 months are required, as are the following laboratory parameters: WBC at least 3,400, platelets greater than 125,000, hematocrit at least 34.0% in men and 31.0% in women, and serum creatinine and total bilirubin each less than 1.5 mg/dl. The following conditions exclude: a greater than 15% weight loss attributable to the present illness; known bleeding disorder; history of other active malignancy within the past 5 years (other than basal or squamous cell carcinoma of the skin outside the radiation portals or in situ carcinoma of the cervix); and any other life-threatening illness. Expected Enrollment At least 3 patients will be treated at each dose level of Porfiromycin; a study duration of 1 year is anticipated. The two patient groups (external beam radiotherapy alone vs. external beam radiotherapy plus brachytherapy) will be accrued and toxicities assessed separately. Outline Nonrandomized study. Patients are treated on Regimen A or B, as appropriate. Regimen A: Radiotherapy plus Adjuvant Single-agent Chemotherapy. External beam radiotherapy using supervoltage sources with energies of at least 4 MeV; plus Porfiromycin, NSC-56410. Regimen B: Radiotherapy plus Adjuvant Single-agent Chemotherapy. External beam radiotherapy as in Regimen A plus brachytherapy using temporary implants of Ir-192 seeds or permanent implants of I-125; plus Porfiromycin. Trial Lead Organizations Yale Cancer Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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