Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer

Nasopharyngeal Cancer Clinical Trial

Official title:

Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05261750
• Other study ID #: CT/NPC/PSI/2022
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 30, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: PT. Prodia Stem Cell Indonesia
• Contact: Budi Sulistya, dr
• Phone: 08121103190
• Email: s3.abudisulistya[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.

Description:

There are controlled group who receives standard medical theraphy (radiotherapy or chemoradiation), one group who receives standard medical theraphy (radiotherapy or chemoradiation) and Auto-dendritic adjuvant therapy, and other group who receives standard medical theraphy (radiotherapy or chemoradiation) and Allo-dendritic-secretomes adjuvant therapy and continued with auto-dendritic therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer
• Patients who have partial response or stable disease or progressive disease after performed standard therapy (radiology or chemoradiation) based on RECIST
• Did not take traditional medicine in the last 2 months.
• Patients can understand the nature of the study and willing to sign informed consent
• Patients who received standard medical (radiology or chemoradiation) up to one additional therapy in the last 1 month.

Exclusion Criteria:

• Patients who are pregnant, planning to pregnant, or breastfeeding
• Patients assessed to require chemoradiation during this study
• Patients who get complete score after undergo standard therapy (radiology or chemoradiation) based on the RECIST
• Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis
• Patients who have creatinin clearance result <40 ml/min, bilirubin serum >1.5x above normal, SGPT-SGOT >5x above normal
• Patients on immunosuppressive medications, such as corticosteroids
• Patients who undergo Major thoracic or abdominal operation
• Patients on high medical risk condition due to uncontrolled infection
• Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiency virus (HIV)
• Patients who have concurrent congestive heart failure history and other heart disease
• Patients who have health conditions assessed by the doctor in charge cannot be included in this clinical trial
• Patients who refuse or did not participate in part or all of the research process

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Biological:
• Auto-Dendritic Adjuvant Therapy
Treatment with standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.
• Allo-Dendritic-Secretome Adjuvant Therapy
Treatment with standard medical therapy (radiotherapy or chemoradiation) and allo-dendritic-secretome adjuvant therapy 2 cc 1 times injection, and then followed by auto-dendritic therapy via intramuscular 3 times injection every 1 week.

Locations

Country	Name	City	State
Indonesia	PT Prodia StemCell Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Karnofsky Performance Status	To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.	Before therapy
Primary	Karnofsky Performance Status	To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.	1 week after therapy
Primary	Karnofsky Performance Status	To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.	1 month after therapy
Primary	Karnofsky Performance Status	To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.	3 months after therapy