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

Colorectal Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860860
• Other study ID #: RUNMC-PRIT2008
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2009
• Last updated: March 16, 2012
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Description:

Pretherapy cycle with IMP-288 labeled In111.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• TF2
TF2: 75-300 mg
• IMP-288 labeled with In111 and Lu177
IMP-288: 100 microgram

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0		first three weeks: daily, thereafter: weekly	Yes
Secondary	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		Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks	Yes