ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)

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:
NCT01730638
First received: November 12, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion


Condition Intervention Phase
Medullary Thyroid Carcinoma
Drug: • TF2 and 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: Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.

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 (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288 [ Time Frame: one week ] [ Designated as safety issue: No ]

    Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart.

    A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.



Secondary Outcome Measures:
  • Sensibilité [ Time Frame: 6 monts after immunoTEP ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • tolerance [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: • TF2 and 68 Ga-IMP-288
    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
Detailed Description:

Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.

A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor

  Eligibility

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

Inclusion Criteria:

  • Histological diagnosis of CMT
  • Calcitonin> 150 pg / ml
  • Complete treatment of the primary tumor
  • at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
  • Age ≥ 18 years
  • Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months.
  • KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months
  • Absence of serious illness or co-morbidity assessed risk
  • Creatinine ≤ 2.5 normal
  • Absence of cancer treatment within 6 weeks prior to the immuno-PET
  • No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
  • Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein
  • Informed consent signed
  • Social Insurance

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Serious illness or co-morbidity assessed risk
  • 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 antibody or protein
  • Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months)
  • Inability intellectual sign consent
  • Patient 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: NCT01730638

Contacts
Contact: Françoise Bodere, PhD, MD 00320240084136 francoise.bodere@chu-nantes.fr
Contact: Evelyne Scotet-Cérato, PhD 0032253482840 evelyne.cerato@chu-nantes.fr

Locations
France
Angers Hospital Recruiting
Angers, France, 49100
Contact: Olivier Couturier, PhD, MD       ocouturier70@me.com   
Principal Investigator: Olivier Couturier, PhD, MD         
Sub-Investigator: Vincent Rohmer, PU, MD         
Nantes Hospital Recruiting
Nantes, France, 44100
Contact: françoise Bodere, PhD, MD    00320240084136    francoise.bodere@chu-nantes.fr   
Contact: Evelyne Scotet-Cérato, PhD    0032253482840    evelyne.cerato@chu-nantes.fr   
Principal Investigator: Francoise Bodere, PhD, MD         
Institut de Cancérologie de l'ouest, René Gauducheau Recruiting
Sant Herblain, France, 44805
Contact: Caroline Rousseau, PhD, MD    0032240679931    "evelyne.cerato@chu-nantes.fr" <evelyne.cerato@chu-nantes.fr>   
Contact: Evelyne Scotet-Cérato, PhD    0032253482840    evelyne.cerato@chu-nantes.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: NCT01730638     History of Changes
Other Study ID Numbers: BRD 11/5-L
Study First Received: November 12, 2012
Last Updated: November 22, 2013
Health Authority: France : Agence National de Sécurité du Médicament (ANSM)

Keywords provided by Nantes University Hospital:
thyroid,
endocrine tumour
Nuclear medicine,
molecular imaging
ImmunoTEP

Additional relevant MeSH terms:
Carcinoma
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014