Colon Cancer Clinical Trial
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer.
Determine the toxicity, maximum tolerated dose, and pharmacokinetics of monoclonal antibody hu3S193 in patients with advanced colorectal carcinoma.
Determine the immune response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study.
Patients receive monoclonal antibody hu3S193 (mAb hu3S193) IV over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest. Patients with stable or responding disease at week 10 receive maintenance mAb hu3S193 weekly. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of mAb hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities.
Histologically proven stage IV colorectal carcinoma.
Failed or refused conventional chemotherapy.
Lewis Y antigen present on more than 50% of tumor cells.
Measurable or evaluable disease.
No central nervous system (CNS) tumor involvement.
Life expectancy: At least 6 weeks.
Granulocyte count greater than 1,500/mm^3.
Platelet count greater than 100,000/mm^3.
Bilirubin no greater than 1.0 mg/dL.
Prothrombin time less than 3 times upper limit of normal.
Creatinine no greater than 1.4 mg/dL.
Female patients of childbearing age and male patients must be asked to use effective contraception during the study.
At least 4 weeks since other prior immunotherapy. Exclusion Criteria
New York Heart Association class III or IV heart disease.
Serious infection requiring antibiotics or other serious illness.
Pregnancy or nursing.
History of bleeding gastric ulcers or pancreatitis.
Diabetes mellitus requiring insulin.
Human antimouse antibodies (HAMA).
No prior mouse monoclonal antibody or antibody fragments.
Illness requiring the use of steroids or other anti-inflammatory agents.
Positive anti-hu3S193 antibody (HAHA) titer.
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There is 1 Location for this study
New York New York, 10021, United States
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