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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

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

NCT ID

NCT00860860

First Posted

March 11, 2009

Last Updated

March 16, 2012

Sponsor

Radboud University Medical Center

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

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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