Combination Trastuzumab With Expanded Natural Killer Cells for Treating HER2-positive Gastric Cancer

June 20, 2016 updated by: Junnian Zheng, Xuzhou Medical University

Combination Trastuzumab With Expanded NK Cells for Treating HER2-positive Gastric Cancer

This trial is to evaluate the safety and effectiveness of activated and expanded in vitro autologous NK cells following trastuzumab treatment for patients Human Epidermal Receptor-2 overexpressing advanced gastric cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tumor antigen-specific monoclonal antibodies, block oncogenic signaling and induce Fcγ receptor (FcγR)-mediated cytotoxicity, are considered to be one of the most successful strategies in cancer therapy. Trastuzumab, a monoclonal antibody directed against HER2, was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric cancer. The use of cellular immunotherapy has increased significantly over the past two decades. Natural killer cells are lymphocytes of the innate immune system that have the ability to recognize and kill malignant cells. There is growing evidence show antibody-dependent cell-mediated cytotoxicity (ADCC) by NK cells contributes to the efficacy of Herceptin. Therefore, methods to enhance ADCC, such as stimulating the innate immune response, may clinically translate to improved antitumor activity. In this study, the investigators sought to enhance the clinical activity of trastuzumab, administrated in combination with expanded autologous NK cells. The enrolled patients are diagnosed HER2+ advanced gastric cancer. The eligible patient will administrate herceptin on 2 days prior to blood collection. The initial dose of herceptin is 8 mg/kg over 90 minutes IV infusion. On day 0 peripheral blood mononuclear cells were separated from 40-50ml blood by density gradient centrifugation. Then were cultured with human NK cell culture medium and stimulation cytokines in a humidified, 5% carbon dioxide incubator for about 14 days. After NK expansion and verification that the resulting NK cells meet purity, gram stain, and endotoxin release criteria, NK cells were washed and resuspended in isotonic sodium chloride. NK cellular therapy conduct 2 cycles per year. The maintenance dose of herceptin monotherapy is 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks. This study will determine the safety and efficacy of this novel combinational therapeutic strategy in HER2 positive gastric cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Huizhong Li, MM
  • Phone Number: 86-0516-85582635
  • Email: lhz@xzmc.edu.cn

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221002
        • Xuzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age equal to 18 years or older;
  • Patients with histologically confirmed HER2 positive advanced gastric cancer through immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);
  • Normal marrow hematopoiesis function: Hemoglobin≥90g/L, White Blood Cell count≥4000/μL, absolute Neutrophil Cell count (ANC)≥1500/μL, Platelet≥100000/μL;
  • Normal important organ function: Total bilirubin≤1.5-fold institutional upper limit of normal (ULN), Aspartate aminotransferase and Alanine aminotransferase≤2.5-fold ULN, Creatinine clearance≥80mL/min;
  • Life expectancy≥6 months;
  • No other serious heart, lung, kidney dysfunction;
  • Quality of life (Karnofsky performance score)≥60;
  • Patient must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

  • Prior allergic reaction or hypersensitivity to cytokines (eg.Interleukin-2);
  • Patients with systemic or local infection requiring anti-infections treatment;
  • Patients currently treated with systemic immunosuppressive agents, including steroids;
  • Patients with active autoimmune disease or history of transplantation requiring steroid treatment;
  • Tested positive for HIV;
  • Pregnant or lactating women;
  • Patients with coagulation disorders;
  • Patients with important organ dysfunction, including cardiac, lung, liver;
  • Patients experiencing a cardiac events (acute coronary syndrome, myocardial infarction or ischemia) within the 3 months;
  • Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trastuzumab + NK cells

On Cycle 1,day -2, patients will receive IV loading dose 8mg/Kg trastuzumab, followed by collection blood on day 0. After NK expansion and verification that the resulting NK cells meet release criteria, NK cells were washed and resuspended in isotonic sodium chloride for intravenous transfusion on day 14.

NK cellular therapy conduct 2 cycles per year. The maintenance dose of trastuzumab monotherapy is 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.
Drug: Trastuzumab + NK cells
NK cellular therapy conduct 2 cycles per year. Herceptin initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.
Other Names:
  • Herceptin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with tumor recurrence metastasis as a Measure of effectiveness
Time Frame: 2 years
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
T cell subsets figures
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junnian Zheng, MD, Xuzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XYFY2016-KL014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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