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Clinical Trials/NCT00860860
NCT00860860CompletedPhase 1

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

Radboud University Medical Center1 site in 1 country20 target enrollmentStarted: July 1, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Time Frame: first three weeks: daily, thereafter: weekly

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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