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

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Medullary Thyroid Carcinoma

Treatments

Drug: • TF2 and 68 Ga-IMP-288

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01730638

PROG/10/94

Details and patient eligibility

About

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

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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