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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier:
NCT00902083
First received: May 11, 2009
Last updated: April 6, 2012
Last verified: February 2010

May 11, 2009
April 6, 2012
June 2009
July 2012   (final data collection date for primary outcome measure)
overall best response rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00902083 on ClinicalTrials.gov Archive Site
progress free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Oral and Maxillofacial Malignant Tumors
  • Drug: p53 gene with surgery
    pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
    Other Name: no other names
  • Procedure: surgery
    remove tumor surgery
    Other Name: no other names
  • Drug: p53 with chemotherapy
    p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy
    Other Name: no other names
  • Drug: p53 gene therapy
    p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
    Other Name: no other names
  • Experimental: surgery plus p53 gene
    using p53 gene therapy before surgery
    Intervention: Drug: p53 gene with surgery
  • Active Comparator: surgery alone
    Surgery without pre-p53 gene therapy
    Intervention: Procedure: surgery
  • Experimental: p53 plus chemotherapy
    p53 gene therapy with concurrent chemotherapy
    Intervention: Drug: p53 with chemotherapy
  • Experimental: p53 gene therapy alone
    Intra-tumor injectio of rAd-p53 gene with no concurrent treatment
    Intervention: Drug: p53 gene therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
July 2012
July 2012   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 85 Years
No
Contact: qing yu, MD 86-755-33065218 qingyu36@hotmail.com
China
 
NCT00902083
rAd-p53-002
No
Shenzhen SiBiono GeneTech Co.,Ltd
Shenzhen SiBiono GeneTech Co.,Ltd
Not Provided
Principal Investigator: Longjiang Li, PhD, MD West China Hospital
Shenzhen SiBiono GeneTech Co.,Ltd
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP