Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma (RIT in MTC)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: Thyroid Neoplasms

Treatments: Drug: bispecific antibody and di-DTPA-131I

Study type: Interventional

Funder types: Other

Identifiers

NCT00467506

BRD 03/2-U

Details and patient eligibility

About

Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 18 -75 years
• Karnofsky ≥ 70%
• Histological diagnosis of medullary thyroid carcinoma
• Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years
• Normal liver and renal functions
• Granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3
• No immunization
• Consent form signed

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)