Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: monoclonal antibody Hu3S193 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- 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.
Eligibility| 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
- 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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006046 History of Changes |
| Other Study ID Numbers: | CDR0000068062, MSKCC-00005, NCI-G00-1820 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013