Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging

Colonic Neoplasms Clinical Trial

Official title:

Radioimmunodetection of CEA-Producing Tumors Using a Bispecific Antibody Pre-targeting Method and an In-Labeled Peptide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185081
• Other study ID #: PRISCO
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2005
• Last updated: April 6, 2016
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: April 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety of the peptide and antibody and at the same time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.

Description:

Colo-rectal cancer has an incidence of 8000 cases per year in The Netherlands. Eventually 50% of them will die as a consequence of this disease.

Treatment consists of resection of the primary tumor, followed by adjuvant chemotherapy in some patients. The chemotherapeutical agents, however, are only moderately effective with regard to increase of survival. New treatment modalities are therefore desirable.

Radioimmunotherapy using radioactive labelled antibodies have proven to be effective in hematologic malignancies. Due to slow absorption in solid tumors however an effective radiation dose is not yet achieved.

The aim of our study is to bypass this slow tumor uptake by the use of pre-targeting. We therefore use an unlabeled bispecific antibody infusion. This will be followed several days later by the infusion of a radiolabeled peptide that binds to the bispecific antibody.

We hypothesise that this small peptide will be readily absorbed by the tumor which is pre-saturated by the bispecific antibody. As a consequence a higher radiation dose can be given with a lower toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years of age

• Histologic or cytologic diagnosis of colorectal cancer

• Karnofsky performance status >70%

Exclusion Criteria:

• Pregnant or lactating women

• Severe anorexia

• Active second primary malignancy

• Chemotherapy or radiotherapy within four weeks of study entry

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Drug:
• Indium labeled IMP-205xm734

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre Nijmegen	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Immunomedics, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734
Primary	Tumor targeting of In-IMP-205 in patients with colorectal carcinoma
Primary	Pharmacokinetics, biodistribution and dosimetry of In-IMP-205