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

NCT ID: NCT00467506

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2011-01-31

Brief Summary

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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)

Detailed Description

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Conditions

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Thyroid Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bispecific antibody and di-DTPA-131I

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Francoise Bodere, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Centre François Baclesse

Caen, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

hôpital du Cluzeau

Limoges, , France

Site Status

CHU

Lyon, , France

Site Status

Hôpital de la timone

Marseille, , France

Site Status

CHU

Nantes, , France

Site Status

CHU

Rouen, , France

Site Status

Centre René Huguenin

Saint-Cloud, , France

Site Status

Centre René Gauducheau

Saint-Herblain, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Centre Claudius Régaud

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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BRD 03/2-U

Identifier Type: -

Identifier Source: org_study_id