Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Colorectal Cancer	Biological: monoclonal antibody Hu3S193	Phase 1

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
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

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

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

More Information

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ClinicalTrials.gov Identifier:	NCT00006046 History of Changes
Other Study ID Numbers:	CDR0000068062; MSKCC-00005; NCI-G00-1820
First Posted:	May 21, 2003
Last Update Posted:	February 9, 2009
Last Verified:	March 2003

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