Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
Primary Purpose
Colonic Neoplasms
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Indium labeled IMP-205xm734
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring colon cancer, radioimmunoscintigraphy, colon-specific antigen,, radioimmunotherapy,, radioimmunodetection
Eligibility 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
Sites / Locations
- Radboud University Medical Centre Nijmegen
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00185081
First Posted
September 15, 2005
Last Updated
April 6, 2016
Sponsor
Radboud University Medical Center
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00185081
Brief Title
Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
Official Title
Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Gilead Sciences
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
colon cancer, radioimmunoscintigraphy, colon-specific antigen,, radioimmunotherapy,, radioimmunodetection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indium labeled IMP-205xm734
Primary Outcome Measure Information:
Title
Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734
Title
Tumor targeting of In-IMP-205 in patients with colorectal carcinoma
Title
Pharmacokinetics, biodistribution and dosimetry of In-IMP-205
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Oyen, MD PhD
Organizational Affiliation
Radboud University Medical Centre Nijmegen
Official's Role
Study Director
Facility Information:
Facility Name
Radboud University Medical Centre Nijmegen
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
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Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging
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