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Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sydney Welt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068062

NCT ID:

NCT00006046

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021