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

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)

Completed

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre François Baclesse, Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bispecific antibody and di-DTPA-131I

Drug

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: RIT in MTC

Important dates

Study start: 2004
Primary completion: 2011
Study completion: 2011
First posted: Apr 30, 2007
Registry last updated: Nov 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed