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Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma (RIT in MTC)

Primary Purpose

Thyroid Neoplasms

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
bispecific antibody and di-DTPA-131I
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasms focused on measuring Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre François Baclesse
  • CHU de Grenoble
  • hôpital du Cluzeau
  • CHU
  • Hôpital de la timone
  • CHU
  • CHU
  • Centre René Huguenin
  • Centre René Gauducheau
  • Centre Paul Strauss
  • Centre Claudius Régaud

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 27, 2007
Last Updated
November 10, 2011
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00467506
Brief Title
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Acronym
RIT in MTC
Official Title
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms
Keywords
Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bispecific antibody and di-DTPA-131I

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francoise Bodere, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
hôpital du Cluzeau
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Hôpital de la timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76230
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
ZIP/Postal Code
440805
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Centre Claudius Régaud
City
Toulouse
ZIP/Postal Code
31052
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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