NCT00902083: 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

Status unknown Phase 4 Last updated 6 April 2012

What this trial tests

Phase 4 trial testing p53 gene with surgery in Advanced Oral and Maxillofacial Malignant Tumors in 600 participants. Status unknown.

Timeline

1 June 2009

Primary endpoint
1 July 2012

1 July 2012

Quick facts

Lead sponsor	Shenzhen SiBiono GeneTech Co.,Ltd
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	600
Start date	1 June 2009
Primary completion	1 July 2012
Estimated completion	1 July 2012
Sites	1 location across China

Drugs / interventions tested

• p53 gene with surgery — full drug profile →
• surgery
• p53 with chemotherapy — full drug profile →
• p53 gene therapy — full drug profile →

Conditions studied

• Advanced Oral and Maxillofacial Malignant Tumors — all drugs for Advanced Oral and Maxillofacial Malignant Tumors →

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd — full company profile →

Who can join

Adults 18 to 85, any sex, with Advanced Oral and Maxillofacial Malignant Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• overall best response rate
  Time frame: 3 years

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. p53: From Fundamental Biology to Clinical Applications in Cancer.
   Capuozzo M, Santorsola M, Bocchetti M, Perri F, et al · · 2022 · cited 49× · PMID 36138802 · DOI 10.3390/biology11091325
2. Combining Oncolytic Virotherapy with p53 Tumor Suppressor Gene Therapy.
   Bressy C, Hastie E, Grdzelishvili VZ. · · 2017 · cited 38× · PMID 28480326 · DOI 10.1016/j.omto.2017.03.002
3. From regulation to deregulation of p53 in hematologic malignancies: implications for diagnosis, prognosis and therapy.
   Ahmadi SE, Rahimian E, Rahimi S, Zarandi B, et al · · 2024 · cited 15× · PMID 39538363 · DOI 10.1186/s40364-024-00676-9