Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006046
First received: July 5, 2000
Last updated: February 6, 2009
Last verified: March 2003

July 5, 2000
February 6, 2009
January 2000
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Complete list of historical versions of study NCT00006046 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Colorectal Cancer
Biological: monoclonal antibody Hu3S193
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006046
CDR0000068062, MSKCC-00005, NCI-G00-1820
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sydney Welt, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP