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Clinical Study of EBV-LMP1 Targeted DNAzyme to Treat Nasopharyngeal Carcinoma (NPC-DZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449942
First Posted: October 10, 2011
Last Update Posted: October 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun lunquan, Xiangya Hospital of Central South University
  Purpose
The purpose of this study is to determine whether an EBV-LMP1 targeted DNAzyme is effective in radiosensitization of nasopharyngeal carcinoma in combination with standard radiation therapy.

Condition Intervention Phase
Nasopharyngeal Carcinoma Biological: DNAzyme targeting EBV-LMP1 (DZ1) Other: Saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I/II Study of EBV-LMP1 Targeted DNAzyme in Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun lunquan, Xiangya Hospital of Central South University:

Primary Outcome Measures:
  • Tumor regression rate measured by MRI [ Time Frame: Two years ]
    Tumor growth is measured using MRI weekly from week 1 to week 7, followed by six-monthly measures until week 104.


Secondary Outcome Measures:
  • Tumor vasculature permeability and EBV DNA copies [ Time Frame: Two years ]
    Tumor vasculature permeability is measured using DCE-MRI from week 1 to week 52. EBV DNA copies are measured monthly up to 24 months.EBV cpoies are measured by quantitative PCR.


Enrollment: 40
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DZ1
DZ1 group receives DZ1 intratumoral injection in combination with radiation therapy.
Biological: DNAzyme targeting EBV-LMP1 (DZ1)

DZ1 in saline is administrated by intratumoral injection two hours prior to radiation therapy from week 1 to week 7 on Monday and Thursday. Dosage for each injection is 12 mg in 0.1 mL (200 micrograms per kilogram body weight.

The radical radiotherapy is given to patients 5 times per week with 2 Gy of each treatment. The entire procedure lasts seven weeks.

Other: Saline

0.1 mL of saline is administrated by intratumoral injection two hours prior to radiation therapy from week 1 to week 7 on Monday and Thursday.

The radical radiotherapy is given to patients 5 times per week with 2 Gy of each treatment. The entire procedure lasts seven weeks.

Placebo Comparator: Saline
Placebo group receives saline injection in combination with radiation therapy.
Biological: DNAzyme targeting EBV-LMP1 (DZ1)

DZ1 in saline is administrated by intratumoral injection two hours prior to radiation therapy from week 1 to week 7 on Monday and Thursday. Dosage for each injection is 12 mg in 0.1 mL (200 micrograms per kilogram body weight.

The radical radiotherapy is given to patients 5 times per week with 2 Gy of each treatment. The entire procedure lasts seven weeks.

Other: Saline

0.1 mL of saline is administrated by intratumoral injection two hours prior to radiation therapy from week 1 to week 7 on Monday and Thursday.

The radical radiotherapy is given to patients 5 times per week with 2 Gy of each treatment. The entire procedure lasts seven weeks.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of nasopharyngeal squamous carcinoma
  • EBV-LMP1 positive
  • Signed Informed Consent Form

Exclusion Criteria:

  • Abnormal laboratory results within 45 days prior to study entry
  • Participation in any study involving an experimental drug or an experimental medical device in 30 days prior to study entry
  • Current pregnancy
  • Inability to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449942


Locations
China, Hunan
XiangYa Hospital, Central South University
Changsha, Hunan, China, 410078
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
Principal Investigator: Lun-Quan Sun, PhD Xiangya Hospital, Central South University, Changsha, China
  More Information

Publications:
Yang L, Lu Z, Ma X, Cao Y, Sun LQ. A therapeutic approach to nasopharyngeal carcinomas by DNAzymes targeting EBV LMP-1 gene. Molecules. 2010 Sep 1;15(9):6127-39. doi: 10.3390/molecules15096127. Review.
Lu ZX, Ma XQ, Yang LF, Wang ZL, Zeng L, Li ZJ, Li XN, Tang M, Yi W, Gong JP, Sun LQ, Cao Y. DNAzymes targeted to EBV-encoded latent membrane protein-1 induce apoptosis and enhance radiosensitivity in nasopharyngeal carcinoma. Cancer Lett. 2008 Jul 8;265(2):226-38. doi: 10.1016/j.canlet.2008.02.019. Epub 2008 Mar 18.
Lu ZX, Ye M, Yan GR, Li Q, Tang M, Lee LM, Sun LQ, Cao Y. Effect of EBV LMP1 targeted DNAzymes on cell proliferation and apoptosis. Cancer Gene Ther. 2005 Jul;12(7):647-54.
Dass CR, Saravolac EG, Li Y, Sun LQ. Cellular uptake, distribution, and stability of 10-23 deoxyribozymes. Antisense Nucleic Acid Drug Dev. 2002 Oct;12(5):289-99.
Sun LQ, Cairns MJ, Saravolac EG, Baker A, Gerlach WL. Catalytic nucleic acids: from lab to applications. Pharmacol Rev. 2000 Sep;52(3):325-47. Review.
Cairns MJ, Hopkins TM, Witherington C, Wang L, Sun LQ. Target site selection for an RNA-cleaving catalytic DNA. Nat Biotechnol. 1999 May;17(5):480-6.
Cao Y, DePinho RA, Ernst M, Vousden K. Cancer research: past, present and future. Nat Rev Cancer. 2011 Sep 15;11(10):749-54. doi: 10.1038/nrc3138. Review.
Zheng H, Li LL, Hu DS, Deng XY, Cao Y. Role of Epstein-Barr virus encoded latent membrane protein 1 in the carcinogenesis of nasopharyngeal carcinoma. Cell Mol Immunol. 2007 Jun;4(3):185-96. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sun lunquan, Director, Center for Molecular Medicine, Central South University, Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT01449942     History of Changes
Other Study ID Numbers: CSU-863-DZ
First Submitted: October 4, 2011
First Posted: October 10, 2011
Last Update Posted: October 10, 2011
Last Verified: October 2011

Keywords provided by Sun lunquan, Xiangya Hospital of Central South University:
Nasopharyngeal carcinoma
EBV
LMP1

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases


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