rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

NCT00902122 | Unknown Phase 4

• 1 other identifier: rAd-p53-003
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Thyroid Tumors

Keywords

p53 gene; thyroid; gene therapy; malignant tumors

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  3 years

Secondary Outcomes (1)

• Progress-free survival

  3 years

Study Arms (4)

1

EXPERIMENTAL

Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.

Drug: rAd-p53 gene

2

ACTIVE COMPARATOR

surgery

Procedure: surgery

3

EXPERIMENTAL

p53 gene therapy

Drug: p53 gene therapy

4

ACTIVE COMPARATOR

p53 gene therapy plus radioactive iodine

Radiation: p53 gene therapy with radioactive iodine

Interventions

rAd-p53 gene DRUG

pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times

1

surgery PROCEDURE

removal of thyroid tumor

2

p53 gene therapy DRUG

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

3

p53 gene therapy with radioactive iodine RADIATION

p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen SiBiono GeneTech Co.,Ltd: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610002, China

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases; Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Jingqiang Zhu, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

aiqi wang, MD

CONTACT

86-755-33065218; aiqi.wang@sibiono.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 14, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 9, 2012

Record last verified: 2010-02

Locations

CN (1)