rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors - Full Text View

Sponsor:	Shenzhen SiBiono GeneTech Co.,Ltd
Information provided by:	Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier:	NCT00902122

Purpose

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.

Condition	Intervention	Phase
Advanced Malignant Thyroid Tumors	Drug: rAd-p53 gene Procedure: surgery Drug: p53 gene therapy Radiation: p53 gene therapy with radioactive iodine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery Thyroid Cancer

Drug Information available for: Cadexomer iodine Iodine Thyroid

U.S. FDA Resources

Further study details as provided by Shenzhen SiBiono GeneTech Co.,Ltd:

Primary Outcome Measures:

Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progress-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	May 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental p53 gene therapy before surgery	Drug: rAd-p53 gene pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
2: Active Comparator surgery	Procedure: surgery removal of thyroid tumor
3: Experimental p53 gene therapy	Drug: p53 gene therapy p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
4: Active Comparator p53 gene therapy plus radioactive iodine	Radiation: p53 gene therapy with radioactive iodine p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced stages of thyroid malignant tumors (stage III and VI)
At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
Histologically confirmed Oral and Maxillofacial malignant tumors
No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
Age: 18-85 years old
Expected to survive more 12 weeks
ECOG:0-2
Neutrophils≥1.5×109/L,Platelet≥ 80×109/L, Hb≥80g/L, bilitubin≤2mg/dl,ALT and AST ≤2×institutional upper limit of normal, Cr ≤1.5×institutional upper limit of normal,coagulation tests (PTT and INR) within normal range
Subject provided signed informed consent -

Exclusion Criteria:

Hypersensitive to study drug
Tumor(s) locate very close to important blood vessels and nerves, which affect injection
With a coagulation and bleeding disorder
With uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness
Local infection close to injection site or systemic infection
Pregnant or lactating
Principle investigator consider not suitable

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902122

Contacts

Contact: aiqi wang, MD

86-755-33065218

aiqi.wang@sibiono.com

Locations

China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610002

Sponsors and Collaborators

Shenzhen SiBiono GeneTech Co.,Ltd

Investigators

Principal Investigator:

Jingqiang Zhu, MD,PhD

Department Of Thyroid and breast Surgery, West China hospital, Sichuan University

More Information

No publications provided

Responsible Party:	Shenzhen SiBiono GeneTech Co.,Ltd ( Beryl Chen/director of clinical operation )
Study ID Numbers:	rAd-p53-003
Study First Received:	May 12, 2009
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00902122 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:

p53 gene
thyroid
gene therapy
malignant tumors

Additional relevant MeSH terms:

Anti-Infective Agents
Thyroid Neoplasms
Growth Substances
Physiological Effects of Drugs
Endocrine System Diseases
Trace Elements
Pharmacologic Actions
Anti-Infective Agents, Local

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Iodine
Micronutrients
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009