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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00467506
Other study ID # BRD 03/2-U
Secondary ID
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


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, 

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