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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Antibodies; Antibodies, Bispecific; Immunoglobulins

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.