Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer - Full Text View

Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer (PRIT2008)

This study is currently recruiting participants.

Verified by Radboud University, July 2009

First Received: March 11, 2009 Last Updated: July 15, 2009 History of Changes

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00860860

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: first three weeks: daily, thereafter: weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

pharmacokinetics and biodistribution of TF2 and Lu-177-labeled IMP-288, sensitivity of pretargeted imaging with In-111-labeled IMP-288, and tumor response using RECIST criteria [ Time Frame: Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks ] [ Designated as safety issue: Yes ]

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)

Intervention Details:

TF2: 75-300 mg

IMP-288: 100 microgram

Detailed Description:

Pretherapy cycle with IMP-288 labeled In111.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
WHO performance status: 0 or 1
Having normal hematological function: Neutrophils > 1.5 x 109/l; Platelet count > 150 x 109/l, without transfusion during the previous month; Hemoglobin > 5.6 mmol/l
Total bilirubin < 2 x upper limit of normal (ULN)
ASAT, ALAT < 3 x ULN
Serum creatinine < 2 x ULN
Cockcroft clearance > 50 ml/min
Negative pregnancy test for women of child¬bearing potential (urine or serum)
Age over 18 years
Ability to provide written informed consent

Exclusion Criteria:

Known metastases to the brain
Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
Cardiac disease with New York Heart Association classification of III or IV
Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status
Life expectancy shorter than 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860860

Contacts

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

Locations

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

Sponsors and Collaborators

Radboud University

Investigators

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

More Information

No publications provided

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)

Keywords provided by Radboud University:

radioimmunotherapy
pretargeting
bispecific antibody
lutetium 177
phase I clinical trial

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 10, 2009