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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006046 |
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.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: monoclonal antibody Hu3S193 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma |
Study Start Date: | January 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage IV colorectal carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Sydney Welt, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068062, MSKCC-00005, NCI-G00-1820 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006046 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Digestive System Neoplasms Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Carcinoma Antibodies, Monoclonal Antibodies Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |
Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Antibodies, Monoclonal Neoplasms Antibodies Neoplasms by Site Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |