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

Nantes University Hospital

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Thyroid Neoplasms

Interventions

bispecific antibody and di-DTPA-131IDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Centre François Baclesse

Caen, France

CHU de Grenoble

Grenoble, France

hôpital du Cluzeau

Limoges, France

CHU

Lyon, France

Data from ClinicalTrials.gov

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