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Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma (RIT in MTC)

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ClinicalTrials.gov Identifier: NCT00467506
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : November 11, 2011
Sponsor:
Information provided by:
Nantes University Hospital

Study Description
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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)

Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Drug: bispecific antibody and di-DTPA-131I Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Study Start Date : May 2004
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467506


Locations
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France
Centre François Baclesse
Caen, France, 14076
CHU de Grenoble
Grenoble, France, 38043
hôpital du Cluzeau
Limoges, France, 87042
CHU
Lyon, France, 69394
Hôpital de la timone
Marseille, France, 13385
CHU
Nantes, France, 44093
CHU
Rouen, France, 76230
Centre René Huguenin
Saint Cloud, France, 92210
Centre René Gauducheau
Saint Herblain, France, 440805
Centre Paul Strauss
Strasbourg, France, 67065
Centre Claudius Régaud
Toulouse, France, 31052
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Francoise Bodere, MD CHU de Nantes
More Information
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ClinicalTrials.gov Identifier: NCT00467506     History of Changes
Other Study ID Numbers: BRD 03/2-U
First Posted: April 30, 2007    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011
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
Additional relevant MeSH terms:
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Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
 Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs