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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun lunquan, Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier:
NCT01449942
First received: October 4, 2011
Last updated: October 6, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Xiangya Hospital of Central South University:

Primary Outcome Measures:
  • Tumor regression rate measured by MRI [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Study First Received: October 4, 2011
Last Updated: October 6, 2011
Health Authority: China: Ministry of Science and Technology

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

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

ClinicalTrials.gov processed this record on October 29, 2014