rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors

Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects With Advanced Oral and Maxillofacial Malignant Tumors

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902083

Acronym

rAd-p53

Enrollment

600

Registered

2009-05-14

Start date

2009-06-30

Completion date

2012-07-31

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 Oral and Maxillofacial Malignant Tumors

Keywords

p53 gene, Oral and Maxillofacial, 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 chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.

Detailed description

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral and maxillofacial malignant 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 chemotherapy,or surgery.

Interventions

DRUGp53 gene with surgery

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

PROCEDUREsurgery

remove tumor surgery

DRUGp53 with chemotherapy

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

DRUGp53 gene therapy

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 Oral and Maxillofacial 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 best response rate	3 years

Secondary

Measure	Time frame
progress free survival	3 years

Countries

China

Contacts

Primary Contactqing yu, MD

qingyu36@hotmail.com86-755-33065218

Outcome results

None listed

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