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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
TF2
IMP-288 labeled with In111 and Lu177
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring radioimmunotherapy, pretargeting, bispecific antibody, lutetium 177, phase I clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0

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

Full Information

First Posted
March 11, 2009
Last Updated
March 16, 2012
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00860860
Brief Title
Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer
Acronym
PRIT2008
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Pretherapy cycle with IMP-288 labeled In111.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
radioimmunotherapy, pretargeting, bispecific antibody, lutetium 177, phase I clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TF2
Intervention Description
TF2: 75-300 mg
Intervention Type
Drug
Intervention Name(s)
IMP-288 labeled with In111 and Lu177
Intervention Description
IMP-288: 100 microgram
Primary Outcome Measure Information:
Title
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0
Time Frame
first three weeks: daily, thereafter: weekly
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
O C Boerman, PhD
Organizational Affiliation
RUNMC Department of Nuclear Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
R Schoffelen, MD
Organizational Affiliation
RUNMC Department of Nuclear Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
W JG Oyen, MD PhD
Organizational Affiliation
RUNMC Department of Nuclear Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
W TA van der Graaf, MD PhD
Organizational Affiliation
RUNMC Department of Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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