ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)
This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Nantes University Hospital
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 20, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 3 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart.
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: | 12 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: • TF2 and 68 Ga-IMP-288
- • 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
Other Names:
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 3 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.
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
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 | Not yet 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 20, 2012 |
| 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 Neoplasms Thyroid Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Endocrine System Diseases Antibodies Antibodies, Bispecific Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013