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Phase I Study of 131I-Labeled Humanized Antibody A33 in Patients With Advanced Colorectal Carcinoma

Phase 1
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Phase I Study of 131I-Labeled Humanized Antibody A33 in Patients With Advanced Colorectal Carcinoma

OBJECTIVES: I. Define the toxicity and determine the maximum tolerated dose of iodine I 131
humanized monoclonal antibody A33 (131I-huAb A33) in patients with advanced colorectal
cancer. II. Describe pharmacokinetics and biodistribution of 131I-huAb A33 by external
imaging in these patients. III. Determine the effect of human antihuman antibody response on
pharmacokinetics and targeting of 131I-huAb A33 in this patient population. IV. Determine
whether the dose planning methodology used here can adequately and safely be applied to
routine radioimmunotherapy planning.

OUTLINE: Patients receive iodine I 131 humanized monoclonal antibody A33 (131I-huAb A33) by
IV infusion over 20 minutes every 6-8 days for up to 8 weeks (depending on dosage). Patients
receive a minimum of 6 weeks of treatments. In the absence of disease progression or
unacceptable toxicity, patients are retreated no sooner than 6 weeks after the previous
course. Cohorts of 3-6 patients receive escalating doses of 131I-huAb A33 to determine the
maximum tolerated dose (MTD). The MTD is defined as the highest dose at which no more than 2
of 6 patients experience dose limiting toxicity. Patients are followed for 6 weeks after the
last treatment.

PROJECTED ACCRUAL: There will be 3-24 patients accrued into this study over 16 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer Must have
unresectable (Stage IV) disease or have failed or refused conventional chemotherapy
Measurable disease by conventional imaging methods Liver involvement no greater than 50%
No CNS involvement Not positive for human antimouse antibody titer

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life
expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at
least 150,000/mm3 Prothrombin time less than 1.3 times control Hepatic: Bilirubin no
greater than 1 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No
significant cardiac disease (New York Heart Association class II/IV heart disease) Other:
No serious infection requiring treatment with antibiotics No other serious illness Not
pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse monoclonal antibody or antibody
fragment, chimeric or humanized antibody, or constructs derived from antibodies At least 4
weeks since prior immunotherapy Chemotherapy: No prior mitomycin/radiotherapy combination
At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids or
other antiinflammatory agents Radiotherapy: No prior radiotherapy/mitomycin combination
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Sydney Welt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

Related Keywords:

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



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