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

This study has been completed.
Sponsor:
Information provided by:
Green Cross Cell Corporation
ClinicalTrials.gov Identifier:
NCT00965718
First received: August 24, 2009
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer


Condition Intervention Phase
Pancreatic Cancer
Biological: activated T lymphocyte
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Activated T-lymphocyte ("Immuncell-LC") Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Green Cross Cell Corporation:

Primary Outcome Measures:
  • Disease Control Rate [ Time Frame: Every 2 months from the baseline, up to 16 weeks ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Every visit, up to 16 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 20
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: activated T lymphocyte
    intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.
    Other Name: Immuncell-LC
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00965718

Locations
Korea, Republic of
Yonsei medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
Principal Investigator: Siyoung Song, MD, PhD Yonsei University
  More Information

Additional Information:
No publications provided by Green Cross Cell Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Siyoung Song, Yonsei university college of medicine
ClinicalTrials.gov Identifier: NCT00965718     History of Changes
Other Study ID Numbers: ILC-IIT-01
Study First Received: August 24, 2009
Results First Received: June 25, 2014
Last Updated: September 16, 2014
Health Authority: Korea: The Minitry of Food and Drug Safety

Keywords provided by Green Cross Cell Corporation:
advanced pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014