Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 116 for:    medullary carcinoma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00467506
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : November 11, 2011
Sponsor:
Information provided by:
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE April 27, 2007
First Posted Date  ICMJE April 30, 2007
Last Update Posted Date November 11, 2011
Study Start Date  ICMJE May 2004
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00467506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Official Title  ICMJE Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Neoplasms
Intervention  ICMJE Drug: bispecific antibody and di-DTPA-131I
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467506
Other Study ID Numbers  ICMJE BRD 03/2-U
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francoise Bodere, MD CHU de Nantes
PRS Account Nantes University Hospital
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP