Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003360
First received: November 1, 1999
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with advanced colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Radiation: iodine I 131 monoclonal antibody A33
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of 131I-Labeled Humanized Antibody A33 in Patients With Advanced Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 24
Study Start Date: April 1998
Primary Completion Date: August 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003360

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
Investigators
Study Chair: Sydney Welt, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003360     History of Changes
Other Study ID Numbers: 98-011, MSKCC-98011, NCI-H98-0017
Study First Received: November 1, 1999
Last Updated: January 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014