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

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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Oral and Maxillofacial Malignant Tumors
• Intervention / Treatment: Drug: p53 gene with surgery; Procedure: surgery; Drug: p53 with chemotherapy; Drug: p53 gene therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: qing yu, MD; Phone Number: 86-755-33065218; Email: qingyu36@hotmail.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Longjiang Li, PhD, MD; Phone Number: 86-28-85503389; Email: muzili63@163.com
      • Principal Investigator: Longjiang Li, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: surgery plus p53 gene; using p53 gene therapy before surgery	Drug: p53 gene with surgery; pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times; Other Names: no other names
ACTIVE_COMPARATOR: surgery alone; Surgery without pre-p53 gene therapy	Procedure: surgery; remove tumor surgery; Other Names: no other names
EXPERIMENTAL: p53 plus chemotherapy; p53 gene therapy with concurrent chemotherapy	Drug: p53 with chemotherapy; p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy; Other Names: no other names
EXPERIMENTAL: p53 gene therapy alone; Intra-tumor injectio of rAd-p53 gene with no concurrent treatment	Drug: p53 gene therapy; p53 gene treatment: 10exp12 virus particles per 3 days for 10 times; Other Names: no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall best response rate	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
progress free survival	3 years

Collaborators and Investigators

• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
• Investigators: Principal Investigator: Longjiang Li, PhD, MD, West China Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ANTICIPATED): July 1, 2012
• Study Completion (ANTICIPATED): July 1, 2012

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 13, 2009
• First Posted (ESTIMATE): May 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 9, 2012
• Last Update Submitted That Met QC Criteria: April 6, 2012
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: gene therapy; p53 gene; Oral and Maxillofacial; malignant tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: rAd-p53-002