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

Primary Purpose

Nasopharyngeal Cancer

Status
Recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Auto-Dendritic Adjuvant Therapy
Allo-Dendritic-Secretome Adjuvant Therapy
Sponsored by
PT. Prodia Stem Cell Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer focused on measuring Dendritic Cells, Dendritic Secretomes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PT Prodia StemCell IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Auto-Dendritic Adjuvant Therapy

Allo-Dendritic-secretome and Auto-Dendritic Adjuvant Therapy

Arm Description

Patients will be given standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.

Patients will be given standrad 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
September 23, 2022
Sponsor
PT. Prodia Stem Cell Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05261750
Brief Title
Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
Official Title
Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT. Prodia Stem Cell Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer
Keywords
Dendritic Cells, Dendritic Secretomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auto-Dendritic Adjuvant Therapy
Arm Type
Experimental
Arm Description
Patients will be given standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.
Arm Title
Allo-Dendritic-secretome and Auto-Dendritic Adjuvant Therapy
Arm Type
Experimental
Arm Description
Patients will be given standrad 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.
Intervention Type
Biological
Intervention Name(s)
Auto-Dendritic Adjuvant Therapy
Intervention Description
Treatment with standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.
Intervention Type
Biological
Intervention Name(s)
Allo-Dendritic-Secretome Adjuvant Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Karnofsky Performance Status
Description
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.
Time Frame
Before therapy
Title
Karnofsky Performance Status
Description
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.
Time Frame
1 week after therapy
Title
Karnofsky Performance Status
Description
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.
Time Frame
1 month after therapy
Title
Karnofsky Performance Status
Description
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.
Time Frame
3 months after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Budi Sulistya, dr
Phone
08121103190
Email
s3.abudisulistya@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Retna Sartika, Dr
Email
c.sartika@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rima Haifa, B.Sc
Organizational Affiliation
Prodia Stem Cell Indonesia
Official's Role
Study Chair
Facility Information:
Facility Name
PT Prodia StemCell Indonesia
City
Jakarta
Country
Indonesia
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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