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

March 16, 2012 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Colorectal Neoplasms

Intervention / Treatment

Detailed Description

Pretherapy cycle with IMP-288 labeled In111.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Nijmegen, Netherlands, 6525 GA
    - Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0 Time Frame: first three weeks: daily, thereafter: weekly	first three weeks: daily, thereafter: weekly

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)