Spots Global Cancer Trial Database for rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

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Trial Identification

Brief Title: rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

Official Title: Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Radioactive Iodine , or Combination With Surgery in Subjects With Advanced Malignant Thyroid Tumors

Study ID: NCT00902122

Conditions

Advanced Malignant Thyroid Tumors

Interventions

rAd-p53 gene

surgery

p53 gene therapy

p53 gene therapy with radioactive iodine

Study Description

Brief Summary: This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.

Detailed Description: Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with with concurrent radioactive iodine, or combination with surgery for treatment of advanced malignant thyroid tumors(stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS). The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with radioactive iodine,or surgery.