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Imaging Colo-Rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging

This study is currently recruiting participants.
Verified by Radboud University, February 2007

Sponsors and Collaborators: Radboud University
Immunomedics, Inc.
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00185081
  Purpose

The purpose of this study is to test the safety of the peptide and antibody and at the same time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.


Condition Intervention Phase
Colonic Neoplasms
Drug: Indium labeled IMP-205xm734
Phase I

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:   Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-Targeting Method and an In-Labeled Peptide

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734
  • Tumor targeting of In-IMP-205 in patients with colorectal carcinoma
  • Pharmacokinetics, biodistribution and dosimetry of In-IMP-205

Estimated Enrollment:   42
Study Start Date:   July 2005
Estimated Study Completion Date:   December 2007

Detailed Description:

Colo-rectal cancer has an incidence of 8000 cases per year in The Netherlands. Eventually 50% of them will die as a consequence of this disease.

Treatment consists of resection of the primary tumor, followed by adjuvant chemotherapy in some patients. The chemotherapeutical agents, however, are only moderately effective with regard to increase of survival. New treatment modalities are therefore desirable.

Radioimmunotherapy using radioactive labelled antibodies have proven to be effective in hematologic malignancies. Due to slow absorption in solid tumors however an effective radiation dose is not yet achieved.

The aim of our study is to bypass this slow tumor uptake by the use of pre-targeting. We therefore use an unlabeled bispecific antibody infusion. This will be followed several days later by the infusion of a radiolabeled peptide that binds to the bispecific antibody.

We hypothesise that this small peptide will be readily absorbed by the tumor which is pre-saturated by the bispecific antibody. As a consequence a higher radiation dose can be given with a lower toxicity.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • > 18 years of age
  • Histologic or cytologic diagnosis of colorectal cancer
  • Karnofsky performance status >70%

Exclusion Criteria:

  • Pregnant or lactating women
  • Severe anorexia
  • Active second primary malignancy
  • Chemotherapy or radiotherapy within four weeks of study entry
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185081

Contacts
Contact: Frits Aarts, MD     +31243619097     f.aarts@chir.umcn.nl    
Contact: Manuel Koppe, MD     M.Koppe@chir.umcn.nl    

Locations
Netherlands, Gelderland
Radboud University Medical Centre Nijmegen     Recruiting
      Nijmegen, Gelderland, Netherlands, 6500 HB
      Contact: Frits Aarts, MD     +31243616421        

Sponsors and Collaborators
Radboud University
Immunomedics, Inc.

Investigators
Study Director:     Wim Oyen, MD PhD     Radboud University Medical Centre Nijmegen    
  More Information


Study ID Numbers:   PRISCO
First Received:   September 15, 2005
Last Updated:   February 28, 2007
ClinicalTrials.gov Identifier:   NCT00185081
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
colon cancer  
radioimmunoscintigraphy  
colon-specific antigen,  
radioimmunotherapy,  
radioimmunodetection  

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008




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