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

July 26, 2018 updated by: Nantes University Hospital

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

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;

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 4 or 5 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different interval time. A last cohort (4 or 5 ): maximum of 21 additional patients with the optimal schedule.

Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours

Cohort II: based on the results of the cohort I :

  1. Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6 nmol of IMP-288 / 30 hours
  2. Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 / 18 hours

  3. Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 / 3nmol IMP- 288 / 24 hours

    Cohort III: based on results of cohort II:

    - Good signal of the tumor : dose reduction, 120 nmol TF2 / 3 nmol IMP-288 / 30 h

    Cohort IV : based on results of cohort III Cohort V : Based on results of cohort IV

    • A last Cohort (VI) : 19 patients with the optimal schedule of injection : 120 nmol TF2 / 3 nmol IMP-288 / 30 h or 120 nmol TF2 / 6 nmol IMP-288 / 30 h

    • In the four weeks prior to the immuno-PET:

    - Clinical examination,

    - CEA and CA15-3,

    - thoraco abdominal pelvic scan, bone scan, FDG-PET,

    - immunohistochemistry ACE on the tumor if possible,

    - Anti-Antibodies if the patient has already received MAb,

    - pregnancy test within 2 days prior to immuno-PET,

    - (creatinine > 2.5 normal) D0: Injection of TF2 D1 to D4: injection of 68 Ga-IMP-288 (depending of the cohort) D0 to D4 : pharmacokinetics, imaging

    Evaluation at 1 month of Immuno-PET:

    • Assessment of the clinical oncologist and

    - histological biopsy and / or surgery performed according to the results of imaging and assessment of the potential clinical impact

    Evaluation at 3 and 6 months of immuno-PET:

    based on the results of immuno-PET, evaluation and therapeutic decision of the oncologist,

    - Imaging (ultrasound, bone scintigraphy, CT or PET FDG),

    - markers

    • Anti-Antibody Search
    • For patient with a cancer treatment a new immuno-PET can be proposed

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Hospital
      • Saint Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

    •• 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
    • Not controlled diabetes
    • Persons protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility, tolerance
Time Frame: 6 months after immunoTEP
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
6 months after immunoTEP
To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods
Time Frame: month 6

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)
month 6

Other Outcome Measures

Outcome Measure
Time Frame
• To assess the tolerance of 150 MBq of 68 Ga-IMP-288
Time Frame: 6 months
6 months
To search for the development of immunization with TF2 and the complex TF2-IMP-288: ELISA
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Gilead Sciences

Investigators

  • Principal Investigator: francoise Bodere, PhD, MD, Nantes Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Actual)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/10/04-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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