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Phase I Study of Transforming Growth Factor-beta-2 Administered as a Mouthwash to Alleviate Stomatitis in Patients Receiving Fluorouracil-Based Chemotherapy for Metastatic Cancer (Summary Last Modified 07/97)
Basic Trial Information
Objectives I. Evaluate the tolerance in patients with fluorouracil-induced stomatitis to transforming growth factor-beta-2 (TGF-beta-2) administered orally at 25, 75, and 250 mcg doses. II. Describe any toxicities of TGF-beta-2 administered orally on this schedule. III. Evaluate the efficacy of TGF-beta-2 in ameliorating fluorouracil-induced stomatitis in these patients. IV. Assess patient compliance regarding mouthwash use and completion of a self-assessment questionnaire. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: --Population Characteristics-- Patients at least 18 years of age receiving fluorouracil-based chemotherapy and who experienced grade 2 stomatitis on prior course No changes in chemotherapy dose anticipated for the next course (i.e., disease is stable or responding) No complicating oral disease No concurrent colony stimulating factors (e.g., GM-CSF) or interferon gamma No pregnant women Effective contraception required of fertile women Expected Enrollment 18 patients who complete 2 courses (1 without and 1 with TGF-beta-2) will be entered within 12 months. Outline Biological Response Modifier Therapy. Recombinant Transforming Growth Factor-beta-2 (Celtrix), TGF-beta-2, diluted in Clear Choice mouthwash. Trial Lead Organizations NCI - Center for Cancer Research
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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