NCT00467506
Completed
Phase 2
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
ConditionsThyroid Neoplasms
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Thyroid Neoplasms
- Sponsor
- Nantes University Hospital
- Locations
- 9
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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)
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
Study Sites (9)
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