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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

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


Pretherapy cycle with IMP-288 labeled In111.


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 childĀ¬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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

first three weeks: daily, thereafter: weekly

Safety Issue:

Yes

Principal Investigator

O C Boerman, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

RUNMC Department of Nuclear Medicine

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

RUNMC-PRIT2008

NCT ID:

NCT00860860

Start Date:

July 2009

Completion Date:

October 2011

Related Keywords:

  • Colorectal Neoplasms
  • radioimmunotherapy
  • pretargeting
  • bispecific antibody
  • lutetium 177
  • phase I clinical trial
  • Neoplasms
  • Colorectal Neoplasms

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