Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures

May 31, 2023 updated by: Sarcoma Oncology Research Center, LLC
The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.

Study Design:

One hundred mL of blood will be collected in an EDTA container and transported to the laboratory for in vitro isolation and expansion of NK cell cultures.

Two or three weeks later, 25 cu mm of the patient's own tumor will be collected in PBS and transported to the laboratory for co-culture with autologous expanded and enhanced NK cells.

Inclusion Criteria:

Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:

  • Male or Female ≥ 18 years of age
  • Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
  • Patients who are already scheduled for surgery
  • Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
  • Willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria: Patients who do not meet the inclusion criteria.

Methodology:

Male and female subjects > 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.

Study Duration:

The study is expected to take 24-30 months

Statistical Analysis Plan For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate. Assuming the required statistical power of 0.9 with a significance level of 0.05 and effect size of 0.4, an equal sample size of at least 19 is suggested for each group: 1) Untreated, 2) CH-SCP, 3) Nk cells and 4) CH-SCP-NK-based hydrogel. Differences in mean tumor growth and survival rate between the control and experimental groups at each time point will be tested with independent ANOVA followed by Tukey's HSD test as a post-hoc analysis where appropriate.

Baseline Descriptive Statistics Demographics, age, ethnicity, subtypes of sarcoma, number of patients, patients with locally advanced or metastatic will be described using descriptive statistics.

Study Type

Observational

Enrollment (Estimated)

20

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 Backup

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Recruiting
        • Sarcoma Oncology Research Center
        • Contact:
        • Sub-Investigator:
          • Sant P Chawla, MD
        • Principal Investigator:
          • Erlinda M Gordon, MD
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Male and female subjects > 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.

Description

Inclusion Criteria:

  • Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:

    • Male or Female ≥ 18 years of age
    • Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
    • Patients who are already scheduled for surgery
    • Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
    • Willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

Patients who do not meet inclusion criteria.

-

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antitumor activity
Time Frame: 1 month
Inhibition of autologous cancer cell growth in vitro by autologous natural killer cells using an automated cell counter. For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate.
1 month

Collaborators and Investigators

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

Sponsor

Sarcoma Oncology Research Center, LLC

Investigators

  • Principal Investigator: Erlinda M Gordon, MD, Sarcoma Oncology Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 27, 2023

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOC-2205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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