Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety Study of Radio-Labeled huA33 Antibody in Colorectal Cancer
This study is currently recruiting participants.
Verified by Ludwig Institute for Cancer Research, March 2009
First Received: September 13, 2005   Last Updated: March 2, 2009   History of Changes
Sponsor: Ludwig Institute for Cancer Research
Collaborator: Memorial Sloan-Kettering Cancer Center
Information provided by: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00199862
  Purpose

The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect colorectal cancer.


Condition Intervention Phase
Colorectal Neoplasms
Colorectal Cancer
Colorectal Tumor
Colorectal Carcinoma
Drug: Iodine-124 labeled humanized A33 (antibody)
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Pilot Study of Radioimmunodetection of 124-Iodine-Labeled Humanized A33 Antibody (124I-huA33) in Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • To determine and quantify tumor uptake of radiolabeled antibody from measurements with: [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
  • PET imaging/Dosimetry [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
  • Autoradiographs - tumor or biopsy samples [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
  • Ex vivo radioactivity estimates - tumor, normal tissue and serum samples [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
  • Toxicity defined by NCI Common Toxicity Criteria [ Time Frame: Until end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum radioactivity, volume of distribution, and half-life following IV and IA 124I-huA33 [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
  • HAHA levels - measured by plasmon resonance surface (Biacore®) assay [ Time Frame: Until end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Iodine-124 labeled humanized A33 (antibody)
    Patients will receive a single intravenous or intraarterial infusion of 10mg huA33, labeled with 4mCi-10mCi of 124I in 5-30ml of 5% HSA in normal saline (NS), over 5-10 minutes. On study days 2, 3, and/or 4 patients will have the option to receive up to 2g/kg of IVIG. Patients will be evaluated with 124I-huA33 positron-emission tomography (PET) with ex vivo quantitation of tumor uptake.
Detailed Description:

This is an open-label, pilot study of a single 4mCi-10mCi/10mg IV dose of 124I-huA33 in patients with colorectal cancer. Patients will be studied with 124I-huA33 positron-emission tomography (PET), and in the subset of patients scheduled for surgery, based on clinical indications, ex vivo quantitation of tumor uptake will also be performed. Patients will receive a single intravenous or intraarterial infusion of 4 mCi-10mCi /10mg 124I-huA33 in 5-30ml of 5% human serum albumin (HSA), over 5-10 minutes. Patient will either receive the 124I-huA33 intravenously (IV) or intraarterially (IA) to determine if there is an advantage of the IV vs the IA route. Following injection with 124I-huA33, on study days 2, 3, and/ or 4, patients will have the option to receive up to 2g/1kg of Immune Globulin (IVIG).

Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes after completion of IV or IA infusion, on day 2, 3, and/ or 4, and before and after the PET scan on the day of surgery or last imaging day (day 8 + 3). Patients scheduled for surgery will undergo a PET scan of the abdomen and pelvis 1-6 hours prior to surgery.

In those patients undergoing surgery, surgery (or biopsy) will be scheduled to occur day 8 (± 3 days) days after administration of 124I-huA33. Biopsy sites may include tumor, tumor bed, regional nodes, portal, suprapancreatic, celiac nodes and the retroperitoneum. Tumor and normal tissue obtained at surgery (or biopsy), and serum will be measured for estimation of percent-injected dose per gram of tumor, normal liver, and serum. Tissue samples will be obtained for autoradiography and immunohistochemistry as an additional assessment of tumor targeting.

Blood samples to determine immunogenicity will be taken at baseline and at 4 weeks.

Toxicity assessments will be made throughout the study period.

  Eligibility

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

Inclusion Criteria:

  • primary metastatic colorectal carcinoma
  • candidate for clinically indicated surgery/biopsy
  • expected survival of at least 3 months
  • Karnofsky performance status >70 (ECOG0 or 1)
  • Age 18 or older
  • women of childbearing potential with confirmed negative pregnancy test
  • Laboratory results within 2 weeks of study day 1 that show acceptable hematological levels.

Exclusion Criteria:

  • clinically significant cardiac disease
  • Active CNS tumor involvement
  • Previous treatment with A33 or its fragment and/or positive test for huA33 human anti-human antibodies
  • women who are pregnant or breast-feeding
  • participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199862

Contacts
Contact: Christina E Hong 212- 639-7246 hongc@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Steven M Larson, MD     212-639-7373        
Principal Investigator: Steven M Larson, MD            
Principal Investigator: Douglas Wong, MD            
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Steven M Larson, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Ludwig Institute for Cancer Research ( Ralph Venhaus, M.D. )
Study ID Numbers: LUD2001-011
Study First Received: September 13, 2005
Last Updated: March 2, 2009
ClinicalTrials.gov Identifier: NCT00199862     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
huA33
antibody
colorectal cancer
Iodine 124
124I

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Rectal Diseases
Neoplasms by Site
Therapeutic Uses
Iodine
Micronutrients
Immunoglobulins
Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Trace Elements
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Carcinoma
Anti-Infective Agents, Local
Neoplasms
Antibodies
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009