Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety and Efficacy of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515252
• Other study ID #: IVY 01
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2005
• Est. completion date: June 7, 2007

Study information

• Verified date: April 2018
• Source: Ivy Life Sciences, Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.

Description:

This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.

For each indication (cancer of the lung or liver) 10 patients are anticipated to be recruited, making a total of 20 subjects. All subjects will receive treatment as this is a single-arm study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 7, 2007
• Est. primary completion date: November 2, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. subjects had voluntarily given written informed consent

2. subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit

3. subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC

4. subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC

5. subjects' ECOG performance status = 2

6. subjects with life expectancy = 3 months

Exclusion Criteria:

1. subjects with medical history of gout

2. subjects who had participated other clinical trials within 4 weeks before the screening visit

3. subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit

4. subjects with clinically significant diseases other than cancer

5. subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit

6. female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception

7. subjects with history of alcohol, drug or other substance abuse

8. subjects with disease of bacteremia

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma by BCLC Stage
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Lung Neoplasms
• NSCLC Stage IIIB
• NSCLC Stage IV

Intervention

Biological:
• Immune Killer Cells (IKC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ivy Life Sciences, Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety]	Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment	5 months
Secondary	Response Evaluation Criteria in Solid Tumors (RECIST)	Record net changes of tumor sizes	4 months
Secondary	Quality of Life (QOL)	The assessment will be performed using The World Heath Organization Quality of Life Questionnaire (WHOQOL); This questionnaire produces a quality of life profile. It is possible to derive four domain scores. The four domain scores denote an individual's perception of quality of life in each particular domain (1. Physical health 2. Psychological 3. Social relationships 4. Environmental) Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).; The mean score of items within each domain is used to calculate the domain score (min: 0 max: 100); Domain scores are then calculated (divide domain score by 4) to produce a final QOL Score (i.e. higher scores denote higher quality of life min: 0 max:100).	5 months