rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902122

Enrollment

600

Registered

2009-05-14

Start date

2009-05-31

Completion date

2012-08-31

Last updated

2012-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignant Thyroid Tumors

Keywords

p53 gene, thyroid, gene therapy, malignant tumors

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.

Interventions

DRUGrAd-p53 gene

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

PROCEDUREsurgery

removal of thyroid tumor

DRUGp53 gene therapy

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

RADIATIONp53 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Advanced stages of thyroid malignant tumors (stage III and VI) 2. At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm 3. Histologically confirmed Oral and Maxillofacial malignant tumors 4. No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks 5. Age: 18-85 years old 6. Expected to survive more 12 weeks 7. ECOG:0-2 8. 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 9. Subject provided signed informed consent -

Exclusion criteria

1. Hypersensitive to study drug 2. Tumor(s) locate very close to important blood vessels and nerves, which affect injection 3. With a coagulation and bleeding disorder 4. 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 5. Local infection close to injection site or systemic infection 6. Pregnant or lactating 7. Principle investigator consider not suitable

Design outcomes

Primary

Measure	Time frame
Overall Response Rate	3 years

Secondary

Measure	Time frame
Progress-free survival	3 years

Countries

China

Contacts

Primary Contactaiqi wang, MD

aiqi.wang@sibiono.com86-755-33065218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026