Trial record 9 of 222 for:    Open Studies | "Colonic Neoplasms"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00185081
First received: September 15, 2005
Last updated: February 28, 2007
Last verified: February 2007
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-Targeting Method and an In-Labeled Peptide

Resource links provided by NLM:


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
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: NCT00185081

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

Locations
Netherlands
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

No publications provided

ClinicalTrials.gov Identifier: NCT00185081     History of Changes
Other Study ID Numbers: PRISCO
Study First Received: September 15, 2005
Last Updated: February 28, 2007
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

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

ClinicalTrials.gov processed this record on September 15, 2014