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

NCT00965718 | Completed Phase 2 Results

• 1 other identifier: ILC-IIT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Cancer

Keywords

advanced pancreatic cancer

Outcome Measures

Primary Outcomes (3)

• Disease Control Rate

  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

  Every 2 months from the baseline, up to 16 weeks

• Stable Disease(SD)

  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.

  Every 2 months from the baseline, up to 16 weeks

• Progressive Disease(PD)

  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.

  Every 2 months from the baseline, up to 16 weeks

Secondary Outcomes (4)

• Overall Survival (OS)

  Every visit, up to 16 weeks

• Time to Progression

  Every 2 months from the baseline, up to 16 weeks

• Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)

  Every one month from the baseline, up to 16 weeks

• Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)

  Every one month from the baseline, up to 16 weeks

Study Arms (1)

Immuncell-LC group

EXPERIMENTAL

Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour.

Biological: Activated T lymphocyte

Interventions

Activated T lymphocyte BIOLOGICAL

Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour.

Also known as: Immuncell-LC

Immuncell-LC group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient aged 18 to 75
• Patient with pathologically-confirmed, advanced pancreatic cancer
• ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)
• Patient with anticipated survival period of more than 3 months
• Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
• Patient whose blood test, renal function test and liver function test results meet the following conditions.

You may not qualify if:

• 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.)
• Confirmed immunodeficient patient
• 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
• Patient who has received systemic anti-angiogenic agent
• Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
• Obvious myocardial failure or uncontrolled arterial hypertension
• Patient who has experienced serious allergy (judged by the investigator)
• Patient with serious psychological disease (judged by the investigator)
• Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
• Patient who has participated in another clinical trial within the last 4 weeks of the start of study

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (1)

Yonsei medical center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24916038 DERIVED

Related Links

• Research paper

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Moonjae Chung, MD
• Organization: Yonsei university

MJCHUNG@yuhs.ac

82-2-2228-2274

Study Officials

• Siyoung Song, MD, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 26, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 19, 2023
• Results First Posted: September 16, 2014

Record last verified: 2023-07

Locations

KR (1)