- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467506
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma (RIT in MTC)
November 10, 2011 updated by: Nantes University Hospital
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Caen, France, 14076
- Centre François Baclesse
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Grenoble, France, 38043
- CHU de Grenoble
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Limoges, France, 87042
- Hôpital du Cluzeau
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Lyon, France, 69394
- CHU
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Marseille, France, 13385
- Hôpital de la Timone
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Nantes, France, 44093
- CHU
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Rouen, France, 76230
- CHU
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Saint Cloud, France, 92210
- Centre René Huguenin
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Saint Herblain, France, 440805
- Centre Rene Gauducheau
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Strasbourg, France, 67065
- Centre Paul Strauss
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Toulouse, France, 31052
- Centre Claudius Régaud
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francoise Bodere, MD, CHU de Nantes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
April 27, 2007
First Submitted That Met QC Criteria
April 27, 2007
First Posted (Estimate)
April 30, 2007
Study Record Updates
Last Update Posted (Estimate)
November 11, 2011
Last Update Submitted That Met QC Criteria
November 10, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRD 03/2-U
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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