Clinical trial NCT00965718: Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: advanced pancreatic cancer
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration.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.

Eligibility 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

Primary outcomes:
measure: Disease Control Rate
timeFrame: Every 2 months from the baseline, up to 16 weeks
measure: Stable Disease(SD)
timeFrame: Every 2 months from the baseline, up to 16 weeks
measure: Progressive Disease(PD)
timeFrame: Every 2 months from the baseline, up to 16 weeks
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Every visit, up to 16 weeks
measure: Time to Progression
timeFrame: Every 2 months from the baseline, up to 16 weeks
measure: Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
timeFrame: Every one month from the baseline, up to 16 weeks
measure: Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
timeFrame: Every one month from the baseline, up to 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei medical center
Study officials:
affiliation: Yonsei University
name: Siyoung Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.