colorectal neoplasms large bowel cancer
Conditions
Interventions
All patients receive intravenously TF2 and radiolabeled IMP-288. The dose of
IMP-288 will be the same for each patient. Variation in the TF2 dose and the
interval between TF2 and IMP-288 will be exe
cohort 3: 300 mg, 3-days interval
cohort 4: 600 mg, 5-days interval.
Two weeks prior to administration of Lu-177-IMP288, for each individual patient
dosimetric calculations will be performed with a low diagnostic dose of
In-111-IMP
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion 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 funtion: • Neutrophils > 1.5 x 109/l • Platelet count > 150 x 109/l, without transfusion • Hemoglobin > 6 mmol/l • Total bilirubin 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity, as defined in NCI Common Terminology Criteria for Adverse Events (CTCAE v 3.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and biodistribution of bispecific antibody TF2 and Lu-177-labeled IMP-288 peptide; Tumor response using RECIST criteria | — |
Countries
Netherlands
Outcome results
None listed