ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

Medullary Thyroid Carcinoma Clinical Trial

— iTEP-CMT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730638
• Other study ID #: PROG/10/94
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 and 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. some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Medullary Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• • TF2 and 68 Ga-IMP-288

Locations

Country	Name	City	State
France	Angers Hospital	Angers
France	Nantes Hospital	Nantes
France	Institut de Cancérologie de l'ouest, René Gauducheau	Saint-Herblain

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Gilead Sciences, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	tolerance		6 monts after immunoTEP
Other	a second _iTEP if necessary for the follow up of a lesion	with in the follow up of the pateint	6 monts after immunoTEP
Primary	Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288	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.	one week
Secondary	Sensibilité		6 monts after immunoTEP