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

SiBiono

Status and phase: Unknown; Phase 4

Conditions: Advanced Oral and Maxillofacial Malignant Tumors

Treatments: Procedure: surgery; Drug: p53 with chemotherapy; Drug: p53 gene with surgery; Drug: p53 gene therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902083

rAd-p53-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

surgery plus p53 gene

Experimental group

Description:

using p53 gene therapy before surgery

Treatment:

Drug: p53 gene with surgery

surgery alone

Active Comparator group

Description:

Surgery without pre-p53 gene therapy

Treatment:

Procedure: surgery

p53 plus chemotherapy

Experimental group

Description:

p53 gene therapy with concurrent chemotherapy

Treatment:

Drug: p53 with chemotherapy

p53 gene therapy alone

Experimental group

Description:

Intra-tumor injectio of rAd-p53 gene with no concurrent treatment

Treatment:

Drug: p53 gene therapy