Clinical trial NCT05869994: Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures
Official title: Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sarcoma
Lead sponsor: Sarcoma Oncology Research Center, LLC
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Antitumor activity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Sarcoma Oncology Research Center
state: California
Study officials:
affiliation: Sarcoma Oncology Research Center
name: Erlinda M Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monette A, Ceccaldi C, Assaad E, Lerouge S, Lapointe R. Chitosan thermogels for local expansion and delivery of tumor-specific T lymphocytes towards enhanced cancer immunotherapies. Biomaterials. 2016 Jan;75:237-249. doi: 10.1016/j.biomaterials.2015.10.021. Epub 2015 Oct 9.