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Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Therapy Combined With Chemotherapy and Radiotherapy in Treament of Head and Neck Cancer in Advanced Stage


Phase 4
18 Years
65 Years
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Therapy Combined With Chemotherapy and Radiotherapy in Treament of Head and Neck Cancer in Advanced Stage


Primary objectives of this study is to determine the efficacy profiles of rAd-p53
intra-tumor injection alone, with concurrent chemotherapy, with concurrent radiotherapy, or
combination with surgery for treatment of head and neck malignant tumors in advanced stage
(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, radiotherapy or surgery.


Inclusion Criteria:



1. Advanced stages of head and neck 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 head and neck 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Outcome Time Frame:

3 years

Safety Issue:

Yes

Authority:

China: Food and Drug Administration

Study ID:

rAd-p53-001

NCT ID:

NCT00894153

Start Date:

May 2009

Completion Date:

June 2013

Related Keywords:

  • Neoplasms
  • p53 gene
  • head and neck malignent tumors
  • gene therapy
  • Neoplasms
  • Li-Fraumeni Syndrome

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