ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA (iTEPsein)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Nantes University Hospital
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Immunomedics, Inc.
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01730612
First received: November 12, 2012
Last updated: June 27, 2014
Last verified: November 2013
  Purpose

Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma.

Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;


Condition Intervention Phase
HER2 Negative Breast Carcinoma Expressing CEA
Drug: TF2 - 68 Ga-IMP-288:
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study for Optimization of Immuno-PET Pretargeted With Anti-CEA Bispecific Antibody X Anti-HSG TF2 and the Peptide IMP-288 Radiolabeled With Gallium-68 -Pharmacokinetic and Imaging for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288 [ Time Frame: One week ] [ Designated as safety issue: No ]
    Pk blood after injections of TF2 and 68 Ga-IMP-288 and PET imaging semi-quantification with 60 to 120 minutes after injection of 68 Ga-IMP-288


Secondary Outcome Measures:
  • Sensibility, tolerance [ Time Frame: 6 months after immunoTEP ] [ Designated as safety issue: No ]
    sensitivity of the immuno-PET and compare its performance to standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months by RECIST and EORTC

  • To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods [ Time Frame: month 6 ] [ Designated as safety issue: No ]

    6 weeks after initiation of treatment of metastases (after the first iTEP), a second _iTEP with a therapeutic evaluation will be carried out. The examination requirements are identical to those of the first immunoTEP.

    this second iITEP will be evaluated in regard of imaging assessment performed routinely (TAP scanner, FDG-PET, CA15-3 and CEA)



Other Outcome Measures:
  • • To assess the tolerance of 150 MBq of 68 Ga-IMP-288 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To search for the development of immunization with TF2 and the complex TF2-IMP-288: ELISA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: TF2 - 68 Ga-IMP-288:
    ImmunoTEP
    Other Names:
    • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG)
    • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment with current consensus
  • ≥ 18 years
  • Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective contraception continuously for 3 months.
  • Karnofsky ≥ 70 or ECOG 0-1
  • Life expectancy of at least 6 months
  • ACE of the tumor by immunohistochemistry or positive plasma CEA ≥ 10 ng / mL
  • At least one measurable lesion on CT
  • creatinine < 2.5
  • Informed consent signed
  • Social insurance

Exclusion Criteria:

  • Pregnancy or breastfeeding

    • Serious illness or co-morbidity risk assessed
    • History of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix
    • Presence of anti-antibodies in patients who have previously received antibodies
    • Known hypersensitivity to antibodies or proteins
    • intellectual disability to sign the informed consent
    • diabetes
    • Persons protected by law
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730612

Contacts
Contact: Françoise Bodere, PhD, MD 00 32 2 40 08 4136 francoise.bodere@chu-nantes.fr
Contact: Evelyne Scotet-Cérato, PhD 0032 253482840 evelyne.cerato@chu-nantes.fr

Locations
France
Hospital Recruiting
Nantes, France, 44093
Contact: Françoise Bodere, Phd, MD       francoise.bodere@chu-nantes.fr   
Contact: Evelyne Scotet-cérato, PhD    00 32 2 53 48 28 40    evelyne.cerato@chu-nantes.fr   
Principal Investigator: Francoise Bodere, PhD, MD         
Institut de Cancérologie de l'Ouest Recruiting
Saint Herblain, France, 44805
Contact: Caroline rousseau, Phd? MD    0032 240679931    Rousseau Caroline <Caroline.Rousseau@ico.unicancer.fr>   
Principal Investigator: Caroline Rousseau, PhD, MD         
Sponsors and Collaborators
Nantes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
Immunomedics, Inc.
Investigators
Principal Investigator: francoise Bodere, PhD, MD Nantes Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01730612     History of Changes
Other Study ID Numbers: BRD 10/4-O
Study First Received: November 12, 2012
Last Updated: June 27, 2014
Health Authority: France : ANSM

Keywords provided by Nantes University Hospital:
ImmunoTEP
HER2 negative
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Recurrence
Breast Diseases
Disease Attributes
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014