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Phase II Randomized Study Comparing Immunologic Responses of Stage II and III Colorectal Cancer Patients on Adjuvant Therapy Treated with 3H1 Anti-Idiotype Monoclonal Antibody Mixed with Sargramostim Versus 3H1 Anti-Idiotype Monoclonal Antibody Alum Precipitate Mixed with Sargramostim (Summary Last Modified 01/2000)
Alternate Title Monoclonal Antibody Therapy Plus Sargramostim in Treating Patients With Colorectal Cancer
Objectives I. Determine the effect on the immune system of 3H1 anti-idiotype monoclonal antibody mixed with sargramostim (GM-CSF) versus 3H1 anti-idiotype monoclonal antibody alum precipitate mixed with GM-CSF in patients with stage II or III colorectal cancer. II. Monitor toxic effects in these patients. III. Follow patients for recurrent disease. Entry Criteria Disease Characteristics: Histologically proven Stage II and III colorectal cancer -CEA positive Dukes B and C Prior/Concurrent Therapy: Biologic therapy: No prior or concurrent allergy to murine protein Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent use of nonsteroidal anti-inflammatory agents or cimetidine or H2 receptor antagonists No concurrent participation in experimental protocols Patient Characteristics: Age: 18 and over Performance Status: SWOG 0-1 Hematopoietic: Hemoglobin at least 10 g/dL Hepatic: BUN no greater than 1.5 times normal Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Other: No serious medical illness No psychosis Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior malignancies except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Expected Enrollment A total of 30 patients will be accrued for this study. Outline This is a randomized study. Patients receive either intracutaneous injections of 3H1 anti-idiotype antibody with alum or intramuscular injection of 3H1 anti-idiotype antibody with QS-21 adjuvant. Patients receive biweekly treatment for four immunizations and then every four weeks for a total of two years. (These regimens are closed) Patients are randomized to receive one of two treatment arms. Arm I: Patients receive 3H1 anti-idiotype antibody with sargramostim (GM-CSF). Arm II: Patients receive GM-CSF on days 1-7 and 3H1 anti-idiotype antibody with alum on day 5. Patients receive weekly subcutaneous injections for 4 weeks, then then once every 4 weeks for 2 years, then every 8 weeks for 3 years in the absence of disease progression. Trial Lead Organizations Lucille P. Markey Cancer Center at University of Kentucky
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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