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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00860860 |
This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: TF2 Drug: IMP-288 labeled with In111 and Lu177 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer |
Estimated Enrollment: | 20 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Pretherapy cycle with IMP-288 labeled In111.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: R. Schoffelen, MD | +31 24 3619097 | R.Schoffelen@nucmed.umcn.nl |
Contact: W. JG Oyen, MD PhD | +31 24 3614048 | W.Oyen@nucmed.umcn.nl |
Netherlands | |
Radboud University Nijmegen Medical Centre | Recruiting |
Nijmegen, Netherlands, 6525 GA | |
Contact: R. Schoffelen, MD +31 24 3619097 R.Schoffelen@nucmed.umcn.nl | |
Principal Investigator: W JG Oyen, MD PhD | |
Sub-Investigator: R Schoffelen, MD | |
Principal Investigator: W TA van der Graaf, MD PhD | |
Sub-Investigator: O C Boerman, PhD |
Study Chair: | O C Boerman, PhD | RUNMC Department of Nuclear Medicine |
Study Chair: | R Schoffelen, MD | RUNMC Department of Nuclear Medicine |
Principal Investigator: | W JG Oyen, MD PhD | RUNMC Department of Nuclear Medicine |
Principal Investigator: | W TA van der Graaf, MD PhD | RUNMC Department of Medical Oncology |
Responsible Party: | Department of Nuclear Medicine, Radboud University Nijmegen Medical Centre ( Prof.dr. W.J.G. Oyen ) |
Study ID Numbers: | RUNMC-PRIT2008 |
Study First Received: | March 11, 2009 |
Last Updated: | July 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00860860 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Netherlands: Dutch Health Care Inspectorate; Netherlands: Medical Ethics Review Committee (METC) |
radioimmunotherapy pretargeting bispecific antibody lutetium 177 phase I clinical trial |
Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Antibodies, Bispecific Antibodies Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |
Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Antibodies, Bispecific Neoplasms Antibodies Neoplasms by Site Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |