Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

OBJECTIVES: - 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. PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - 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 CNS tumor involvement PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80-100% Life expectancy: - At least 6 weeks Hematopoietic: - Granulocyte count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.0 mg/dL - Prothrombin time less than 1.3 times control Renal: - Creatinine no greater than 1.4 mg/dL Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - No serious infection requiring antibiotics or other serious illness - Not pregnant or nursing - No history of bleeding gastric ulcers or pancreatitis - No diabetes mellitus requiring insulin - Human antimouse antibody (HAMA) negative PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior mouse monoclonal antibody or antibody fragments - At least 4 weeks since other prior immunotherapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy: - No concurrent steroids or other antiinflammatory agents Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - Not specified


NCT ID:

NCT00006046


Primary Contact:

Study Chair
Sydney Welt, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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