Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma (RIT in MTC)
This study has been completed.
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00467506
First received: April 27, 2007
Last updated: November 10, 2011
Last verified: November 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 27, 2007 | ||||
| Last Updated Date | November 10, 2011 | ||||
| Start Date ICMJE | May 2004 | ||||
| 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 Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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 | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Thyroid Neoplasms | ||||
| Intervention ICMJE | Drug: bispecific antibody and di-DTPA-131I | ||||
| Study Arm (s) | 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 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00467506 | ||||
| Other Study ID Numbers ICMJE | BRD 03/2-U | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Nantes University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | 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 |
|||||