NCT00467506

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2004

Longer than P75 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

6.7 years

First QC Date

April 27, 2007

Last Update Submit

November 10, 2011

Conditions

Thyroid Neoplasms

Keywords

Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery

Interventions

bispecific antibody and di-DTPA-131IDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Centre François Baclesse

Caen, 14076, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

hôpital du Cluzeau

Limoges, 87042, France

Location

CHU

Lyon, 69394, France

Location

Hôpital de la timone

Marseille, 13385, France

Location

CHU

Nantes, 44093, France

Location

CHU

Rouen, 76230, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Centre René Gauducheau

Saint-Herblain, 440805, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Claudius Régaud

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Antibodies, Bispecific

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

AntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Francoise Bodere, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Study Start

May 1, 2004

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

FR(11)