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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):
GC Cell Corporation

Tracking Information
First Submitted Date  ICMJE August 24, 2009
First Posted Date  ICMJE August 26, 2009
Results First Submitted Date  ICMJE June 25, 2014
Results First Posted Date  ICMJE September 16, 2014
Last Update Posted Date December 5, 2017
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2014)
  • Disease Control Rate [ Time Frame: Every 2 months from the baseline, up to 16 weeks ]
    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
  • Stable Disease(SD) [ Time Frame: Every 2 months from the baseline, up to 16 weeks ]
    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.
  • Progressive Disease(PD) [ Time Frame: Every 2 months from the baseline, up to 16 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2009)
Radiological test should be operated by CT or MRI [ Time Frame: Every 2 months from the baseline ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
  • Overall Survival (OS) [ Time Frame: Every visit, up to 16 weeks ]
    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 to Progression [ Time Frame: Every 2 months from the baseline, up to 16 weeks ]
    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.
  • Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30) [ Time Frame: Every one month from the baseline, up to 16 weeks ]
    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.
  • Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire) [ Time Frame: Every one month from the baseline, up to 16 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2009)
Overall survival Time to progression Change in tumor marker (CA19-9) QOL Evaluation of safety [ Time Frame: Every visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
Official Title  ICMJE Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Activated T-lymphocyte ("Immuncell-LC") Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer
Brief Summary Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer
Detailed Description

This was designed as a single-center, single group clinical trial, and subjects include patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer.

If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression and the quality of life should be investigated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Biological: Activated T lymphocyte
Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.
Other Name: Immuncell-LC
Study Arms  ICMJE Not Provided
Publications * Chung MJ, Park JY, Bang S, Park SW, Song SY. Phase II clinical trial of ex vivo-expanded cytokine-induced killer cells therapy in advanced pancreatic cancer. Cancer Immunol Immunother. 2014 Sep;63(9):939-46. doi: 10.1007/s00262-014-1566-3. Epub 2014 Jun 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject who signed the written consent form by themselves, protectors or legal representatives prior to the clinical trial after the person in charge explained fully about objectives, procedure and the characteristics of the study drug.
  2. Patient aged 18 to 75
  3. Patient with pathologically-confirmed, advanced pancreatic cancer
  4. ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)
  5. Patient with anticipated survival period of more than 3 months
  6. Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
  7. Patient whose blood test, renal function test and liver function test results meet the following conditions.

Exclusion Criteria:

  1. Patient with the medical history of immunodeficiency or autoimmune disease that could be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes Mellitus, etc.)
  2. Confirmed immunodeficient patient
  3. Patient with the history of cancer other than skin cancer, local prostate cancer or carcinoma in situ of cervix within the last 5 years of the start of study
  4. Patient who has received systemic anti-angiogenic agent
  5. Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
  6. Obvious myocardial failure or uncontrolled arterial hypertension
  7. Patient who has experienced serious allergy (judged by the investigator)
  8. Patient with serious psychological disease (judged by the investigator)
  9. Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
  10. Patient who has participated in another clinical trial within the last 4 weeks of the start of study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00965718
Other Study ID Numbers  ICMJE ILC-IIT-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GC Cell Corporation
Study Sponsor  ICMJE GC Cell Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Siyoung Song, MD, PhD Yonsei University
PRS Account GC Cell Corporation
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP