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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Active 18 to 75 Other BRD 03/2-U
NCT00467506

Trial Description

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)

Eligibility 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 Contact Information

Trial Lead Organizations/Sponsors

CHR Hotel Dieu

Francoise Bodere, MD

Principal Investigator

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

Trial Sites

France

Caen

Centre Regional Francois Baclesse

Stéphane Bardet, MD Principal Investigator

Grenoble

Olivier Chavre, MD Sub-Investigator

CHU de Grenoble - Hopital de la Tronche

Jean Philippe Vuillez, MD Principal Investigator

Limoges

hôpital du Cluzeau

F Archanbeau, MD Principal Investigator

Lyon

Agnes Perrin, MD Sub-Investigator

Claire Houzard, MD Sub-Investigator

CHU

Françoise borson-Chazot, MD Principal Investigator

Marseille

Mundler, MD Principal Investigator

CHU de la Timone

Bernard Conte devolx, MD Sub-Investigator

Nantes

CHR Hotel Dieu

Francoise Bodere, MD Principal Investigator

Paris

CHU Pitie-Salpetriere

C Guillausseau, MD Principal Investigator

Hopital Cochin

florence Tenembaum, MD Principal Investigator

Rouen

Centre Hospitalier Universitaire de Rouen

Jean Marc Khun, MD Principal Investigator

Saint Cloud

Centre Rene Huguenin

Carine Corone, MD Principal Investigator

Saint Herblain

Caroline Rousseau, MD Principal Investigator

Isabelle Resche, MD Sub-Investigator

Centre Regional Rene Gauducheau

boumédienne Bridgi, MD Sub-Investigator

Strasbourg

Centre Paul Strauss

Toulouse

Institut Claudius Regaud

frederic Courbon, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00467506
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.