Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

Phase 2

Completed

• Conditions: Thyroid Neoplasms

• Registration Number: NCT00467506
• Lead Sponsor: Nantes University Hospital

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-10
• Last Update Posted: 2011-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (9)

Centre René Huguenin; 🇫🇷 Saint Cloud, France

Centre François Baclesse; 🇫🇷 Caen, France

hôpital du Cluzeau; 🇫🇷 Limoges, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital de la timone; 🇫🇷 Marseille, France

Centre René Gauducheau; 🇫🇷 Saint Herblain, France

Centre Claudius Régaud; 🇫🇷 Toulouse, France

CHU; 🇫🇷 Rouen, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France