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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965718
• Other study ID #: ILC-IIT-01
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2023
• Source: GC Cell Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• Activated T lymphocyte
Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Overall Survival (OS)	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).	Every visit, up to 16 weeks
Secondary	Time to Progression	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.	Every 2 months from the baseline, up to 16 weeks
Secondary	Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)	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.	Every one month from the baseline, up to 16 weeks
Secondary	Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)	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.	Every one month from the baseline, up to 16 weeks

External Links

•   Research paper