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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colonic Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734

Principal Investigator

Wim Oyen, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

Radboud University Medical Centre Nijmegen

Authority:

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

Study ID:

PRISCO

NCT ID:

NCT00185081

Start Date:

July 2005

Completion Date:

December 2007

Related Keywords:

  • Colonic Neoplasms
  • colon cancer
  • radioimmunoscintigraphy
  • colon-specific antigen,
  • radioimmunotherapy,
  • radioimmunodetection
  • Neoplasms
  • Colonic Neoplasms

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