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Phase II Two-Step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma (RIT in MTC)
This study is currently recruiting participants.
Verified by Nantes University Hospital, April 2007
Sponsored by: Nantes University Hospital
Information provided by: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00467506
  Purpose

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)


Condition Intervention Phase
Thyroid Neoplasms
Drug: bispecific antibody and di-DTPA-131I
Phase II

MedlinePlus related topics: Cancer Thyroid Cancer
Drug Information available for: Immunoglobulins Globulin, Immune Thyroid Calcitonin Calcitonin human Fortical
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study
Official Title: Phase II Two-Step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

Further study details as provided by Nantes University Hospital:

Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467506

Contacts
Contact: Françoise Pr F. Kraeber-Bodéré, MD 0033 2 40 08 47 47 Francoise.bodere@chu-nantes.fr

Locations
France
Centre René Gauducheau Recruiting
Saint Herblain, France, 440805
Sub-Investigator: boumédienne Bridgi, MD            
Sub-Investigator: Isabelle Resche, MD            
Principal Investigator: Caroline Rousseau, MD            
CHU Recruiting
Nantes, France, 44093
Principal Investigator: Francoise Bodere, MD            
CHU Recruiting
Lyon, France, 69394
Principal Investigator: Françoise borson-Chazot, MD            
Sub-Investigator: Claire Houzard, MD            
Sub-Investigator: Agnes Perrin, MD            
CHU de Grenoble Recruiting
Grenoble, France, 38043
Principal Investigator: Jean Philippe Vuillez, MD            
Sub-Investigator: Olivier Chavre, MD            
Hôpital de la Piitié Salpétrière Recruiting
Paris, France, 75 651
Principal Investigator: C Guillausseau, MD            
Hôpital Cochin Recruiting
Paris, France, 75679
Principal Investigator: florence Tenembaum, MD            
CHU Recruiting
Rouen, France, 76230
Principal Investigator: Jean Marc Khun, MD            
hôpital du Cluzeau Recruiting
Limoges, France, 87042
Principal Investigator: F Archanbeau, MD            
Centre François Baclesse Recruiting
Caen, France, 14076
Principal Investigator: Stéphane Bardet, MD            
Centre René Huguenin Recruiting
Saint Cloud, France, 92210
Principal Investigator: Carine Corone, MD            
Centre Claudius Régaud Recruiting
Toulouse, France, 31052
Principal Investigator: frederic Courbon, MD            
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Hôpital de la timone Recruiting
Marseille, France, 13385
Sub-Investigator: Bernard Conte devolx, MD            
Principal Investigator: Mundler, MD            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Francoise Bodere, MD CHU de Nantes
  More Information

Study ID Numbers: BRD 03/2-U
Study First Received: April 27, 2007
Last Updated: April 27, 2007
ClinicalTrials.gov Identifier: NCT00467506  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:
Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery

Study placed in the following topic categories:
Calcitonin
Thyroid Neoplasms
Endocrine System Diseases
Salmon calcitonin
Recurrence
Antibodies, Bispecific
Carcinoma
Calcitonin Gene-Related Peptide
Antibodies
Head and Neck Neoplasms
Thyroid cancer, medullary
Endocrinopathy
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009