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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


Phase 4
18 Years
85 Years
Open (Enrolling)
Both
Advanced Oral and Maxillofacial Malignant Tumors

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Trial Information

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


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.


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 -

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall best response rate

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Longjiang Li, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West China Hospital

Authority:

China: Food and Drug Administration

Study ID:

rAd-p53-002

NCT ID:

NCT00902083

Start Date:

June 2009

Completion Date:

July 2012

Related Keywords:

  • Advanced Oral and Maxillofacial Malignant Tumors
  • p53 gene
  • Oral and Maxillofacial
  • gene therapy
  • malignant tumors
  • Neoplasms
  • Li-Fraumeni Syndrome

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