Treatment of poorly differentiated thyroid carcinoma resistant to conventional therapy, with reverse transcriptase inhibitors. - ND

Conditions: patients affected by thyroid carcinoma
MedDRA version: 9.1Level: HLTClassification code 10043747Term: Thyroid neoplasms

Registration Number: EUCTR2007-000215-28-IT

Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

HISTOLOGICAL DIAGNOSIS OF POORLY DIFFERENTIATED THYROID CARCINOMA PRESENCE OF DISTANT METASTASES DEVOTED OF IODINE UPTAKE NON-SUITABLE FOR SURGICAL THERAPY OR OTHER CONVNETIONAL TREATMENT MODALITIES AGE GREATER THAN 18 YEARS LOSS OF IODINE UPTAKE CHRONIC ACTIVE LIVER DISEASE
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

CHRONIC ACTIVE LIVER DISEASE OTHER MALIGNANCIES DIAGNOSED WITHIN 5 YEARS PREGNANCY AND BREAST FEEDING

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: see above;Primary end point(s): To demonstrate the ability of the drug to re-induce thyroglobulin synthesis, expression of the NIS gene and re-induction of iodine uptake.;Main Objective: TO TEST THE EFFICACY OF REVERSE TRANSCRIPTASE INHIBITORS IN INDUCING RE-DIFFERENTIATION OF UNDIFFERENTIATED THYROID CARCINOMA, THROUGHT RE-INDUCTION OF THYROGLOBULIN SECRETION, NIS GENE EXPRESSION AND IODINE UPTAKE. TO DEMONSTRATE THE PRESENCE OF RADIOIODINE UPTAKE AND EFFICACY IN THE TUMOR AFTER TREATMENT WITH THE DRUG, AS DEMONSTRATED BY A REDUCTION IN TUMOR VOLUME AND NUMBER OF LESIONS. TO DEMONSTRATE A SIGNIFICANT INCREASE IN SURVIVAL.

Secondary Outcome Measures