Status:
COMPLETED
Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer
Lead Sponsor:
Radboud University Medical Center
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-2...
Detailed Description
Pretherapy cycle with IMP-288 labeled In111.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00860860
Start Date
July 1 2009
End Date
October 1 2011
Last Update
March 19 2012
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6525 GA