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

Thyroid Neoplasms Clinical Trial

— RIT in MTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467506
• Other study ID #: BRD 03/2-U
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2007
• Last updated: November 10, 2011
• Start date: May 2004
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	CHU de Grenoble	Grenoble
France	hôpital du Cluzeau	Limoges
France	CHU	Lyon
France	Hôpital de la timone	Marseille
France	CHU	Nantes
France	CHU	Rouen
France	Centre René Huguenin	Saint Cloud
France	Centre René Gauducheau	Saint Herblain
France	Centre Paul Strauss	Strasbourg
France	Centre Claudius Régaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,