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Trial record 5 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00965718
Recruitment Status : Completed
First Posted : August 26, 2009
Results First Posted : September 16, 2014
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Intervention Biological: Activated T lymphocyte
Enrollment 20
Recruitment Details

Patients with advanced pancreatic cancer who showed disease progression during gemcitabine-based chemotherapy were enrolled in this study.

Twenty patients were enrolled between September 2009 and September 2010.

Pre-assignment Details  
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Period Title: Overall Study
Started 20
Completed 16
Not Completed 4
Reason Not Completed
Withdrawal by Subject             4
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
59.2
(41 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 20 participants
20
ECOG-PS   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
0 12
1 7
2 1
[1]
Measure Description:

Eastern Cooperative Oncology Group performance status (ECOG-PS) is used by researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.

"0"-Fully active, able to carry on all pre-disease performance without restriction "1"-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature "2"-Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours

Duration since diagnosis  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 20 participants
9.2
(3.8 to 94.6)
Period of prior chemotherapy  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 20 participants
5.2
(2.0 to 13.9)
Site of metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Liver 9
Lung 6
Lymph node 5
1.Primary Outcome
Title Disease Control Rate
Hide Description

Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

Disease control rate = CR or PR or SD patients / ITT population *100

Time Frame Every 2 months from the baseline, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description:
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25
(3.78 to 46.22)
2.Primary Outcome
Title Stable Disease(SD)
Hide Description Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.
Time Frame Every 2 months from the baseline, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description:
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: number of participants
4
3.Primary Outcome
Title Progressive Disease(PD)
Hide Description Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.
Time Frame Every 2 months from the baseline, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description:
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: number of participants
12
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was calculated from the date of enrollment until death from any cause. And OS was estimated using Kaplan-Meier methods with 95% confidence intervals (CIs).
Time Frame Every visit, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description:
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: weeks
26.6
(8.6 to 44.6)
5.Secondary Outcome
Title Time to Progression
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Time Frame Every 2 months from the baseline, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description:
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: weeks
11
(8.8 to 13.2)
6.Secondary Outcome
Title Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Hide Description QLQ-C30 constitutes a functional scale(physical, role, emotional, cognitive, and social functioning), symptom scores scale(fatigue, nausea/vomiting, pain, dyspnea, constipation, diarrhea, insomnia, appetite loss, financial difficulties), and global QoL scale. With the scores of all scales ranging from 0 to 100, a higher score indicates a better functional scale and a better global QoL scale as well as a worse symptom scores scale.
Time Frame Every one month from the baseline, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description:
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Global health status at baseline 53.65  (29.81)
Global health status at last visit 40.63  (25.98)
Physical functioning at baseline 73.75  (30.64)
Physical functioning at last visit 69.58  (21.63)
Role functioning at baseline 76.04  (32.76)
Role functioning at last visit 59.38  (29.79)
Emotional functioning at baseline 70.31  (20.41)
Emotional functioning at last visit 61.98  (23.56)
Cognitive functioning at baseline 71.88  (24.13)
Cognitive functioning at last visit 68.75  (28.46)
Social functioning at baseline 68.75  (20.97)
Social functioning at last visit 55.21  (27.02)
Fatigue at baseline 40.97  (24.59)
Fatigue at last visit 50.69  (29.25)
Nausea/vomiting at baseline 15.63  (25.44)
Nausea/vomiting at last visit 16.67  (18.26)
Pain at baseline 20.83  (25.46)
Pain at last visit 45.83  (26.87)
Dyspnea at baseline 10.42  (20.07)
Dyspnea at last visit 27.08  (32.70)
Constipation at baseline 16.67  (24.34)
Constipation at last visit 29.17  (40.14)
Diarrhea at baseline 8.33  (25.82)
Diarrhea at last visit 8.33  (19.25)
Insomnia at baseline 14.58  (20.97)
Insomnia at last visit 43.75  (33.82)
Appetite loss at baseline 31.25  (33.26)
Appetite loss at last visit 43.75  (37.94)
Financial difficulties at baseline 27.08  (30.35)
Financial difficulties at last visit 31.25  (33.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immuncell-LC Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments Global health status scores at baseline and final observation point were compared via a 2-sided t-test.
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Hide Description QLQ-PAN26 consists of questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
Time Frame Every one month from the baseline, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description:
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pancreatic pain at baseline 77.08  (23.07)
Pancreatic pain at last visit 60.42  (25.91)
Gastrointestinal at baseline 78.13  (29.01)
Gastrointestinal at last visit 63.54  (29.32)
Jaundice at baseline 93.75  (11.98)
Jaundice at last visit 87.50  (16.67)
Body image at baseline 56.25  (38.91)
Body image at last visit 56.25  (29.74)
Altered bowel habit at baseline 79.17  (24.72)
Altered bowel habit at last visit 61.46  (24.13)
Health satisfaction at baseline 35.42  (24.25)
Health satisfaction at last visit 34.38  (27.53)
Sexuality scale at baseline 55.21  (39.78)
Sexuality scale at last visit 54.17  (34.16)
Bloated abdomen at baseline 35.42  (25.73)
Bloated abdomen at last visit 54.17  (34.16)
Taste changes at baseline 29.17  (29.50)
Taste changes at last visit 43.75  (35.94)
Indigestion at baseline 27.08  (34.89)
Indigestion at last visit 41.67  (31.03)
Flatulence at baseline 20.83  (23.96)
Flatulence at last visit 33.33  (32.20)
Weight loss at baseline 22.92  (33.82)
Weight loss at last visit 27.08  (25.00)
Decreased muscle strength at baseline 31.25  (30.96)
Decreased muscle strength at last visit 43.75  (29.11)
Dry mouth at baseline 25.00  (31.03)
Dry mouth at last visit 45.83  (34.16)
Treatment side effects at baseline 29.17  (36.26)
Treatment side effects at last visit 39.58  (30.35)
Fear for future health at baseline 52.08  (29.74)
Fear for future health at last visit 58.33  (19.25)
Ability to plan ahead at baseline 31.25  (33.26)
Ability to plan ahead at last visit 52.08  (27.13)
Average pain at baseline 1.13  (1.89)
Average pain at last visit 3.19  (2.43)
Time Frame 1 year
Adverse Event Reporting Description Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
 
Arm/Group Title Immuncell-LC Group
Hide Arm/Group Description Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
All-Cause Mortality
Immuncell-LC Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Immuncell-LC Group
Affected / at Risk (%) # Events
Total   7/20 (35.00%)    
Gastrointestinal disorders   
Abdominal pain * 1 [1]  1/20 (5.00%)  2
Ascite * 1  1/20 (5.00%)  1
Haematemesis * 1  1/20 (5.00%)  1
Ileus * 1  1/20 (5.00%)  1
Upper gastrointestinal haemorrhage * 1  1/20 (5.00%)  1
General disorders   
Death * 1  1/20 (5.00%)  1
General physical health deterioration * 1  1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
Regarded as definitely not related to therapy by investigators.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immuncell-LC Group
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Gastrointestinal disorders   
Vomiting * 1  7/20 (35.00%)  9
Nausea * 1  7/20 (35.00%)  7
Abdominal pain * 1  5/20 (25.00%)  7
Diarrhoea * 1  5/20 (25.00%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Moonjae Chung, MD
Organization: Yonsei university
Phone: 82-2-2228-2274
EMail: MJCHUNG@yuhs.ac
Layout table for additonal information
Responsible Party: Green Cross Cell Corporation
ClinicalTrials.gov Identifier: NCT00965718     History of Changes
Other Study ID Numbers: ILC-IIT-01
First Submitted: August 24, 2009
First Posted: August 26, 2009
Results First Submitted: June 25, 2014
Results First Posted: September 16, 2014
Last Update Posted: December 5, 2017