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Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Colorectal Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003360
  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
Drug: iodine I 131 monoclonal antibody A33
Phase I

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Iodine    Cadexomer iodine    Sodium iodide I 131   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   24
Study Start Date:   April 1998

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

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
National Cancer Institute (NCI)

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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066342, MSKCC-98011, NCI-H98-0017
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003360
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer  
stage IV rectal cancer  
recurrent colon cancer  
recurrent rectal cancer  

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Carcinoma
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastrointestinal Neoplasms
Iodine
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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