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

NCT00860860 | Completed Phase 1 DMC

• 1 other identifier: RUNMC-PRIT2008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

radioimmunotherapy; pretargeting; bispecific antibody; lutetium 177; phase I clinical trial

Outcome Measures

Primary Outcomes (1)

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

  first three weeks: daily, thereafter: weekly

Secondary Outcomes (1)

• 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

Interventions

TF2 DRUG

TF2: 75-300 mg

IMP-288 labeled with In111 and Lu177 DRUG

IMP-288: 100 microgram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Indium-111; Lutetium-177

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• O C Boerman, PhD

  RUNMC Department of Nuclear Medicine

  STUDY CHAIR

• R Schoffelen, MD

  RUNMC Department of Nuclear Medicine

  STUDY CHAIR

• W JG Oyen, MD PhD

  RUNMC Department of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

• W TA van der Graaf, MD PhD

  RUNMC Department of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 19, 2012

Record last verified: 2010-08

Locations

NL (1)