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| 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 |
| 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 |
| Estimated Enrollment: | 42 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Frits Aarts, MD | +31243619097 | f.aarts@chir.umcn.nl |
| Contact: Manuel Koppe, MD | M.Koppe@chir.umcn.nl |
| Netherlands, Gelderland | |||||
| Radboud University Medical Centre Nijmegen | Recruiting | ||||
| Nijmegen, Gelderland, Netherlands, 6500 HB | |||||
| Contact: Frits Aarts, MD +31243616421 | |||||
| Radboud University |
| Immunomedics, Inc. |
| 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) |
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