Personalized Treatment Using DST for Cancer

Recruiting at 2 trial locations

Overseen By Diana Azzam, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Newly diagnosed tumors, High cure rate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for selecting cancer treatments for individuals whose cancer has returned or does not respond to standard treatments. Using a Drug Sensitivity Test (DST), doctors can identify which drugs might be most effective for each person's specific cancer type. The trial aims to improve treatment options for those who have tried at least two different therapies without success. Individuals with recurrent cancer who have recently undergone a biopsy or tumor removal and are open to genetic testing might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore personalized treatment options that could potentially enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Drug Sensitivity Test (DST) is safe for cancer treatment?

Research on Drug Sensitivity Testing (DST) for cancer continues, but important safety points must be understood. DST does not involve administering a new drug to patients. Instead, it helps doctors select the best existing drug by testing how cancer cells react in a lab. Thus, DST itself poses no risk to patients, as no new medicine is administered through this process.

Think of DST as a guide. It uses lab tests to determine which drugs might work best for a patient's cancer by testing cancer cells outside the body. Since DST focuses on selecting the right treatment, safety concerns relate more to the drugs doctors might choose afterward, which are typically already used for cancer treatment.

Although no direct safety data for DST is available from the sources, DST is generally considered safe. It aids in making informed decisions rather than introducing new treatments directly. Always consult healthcare providers to understand the options and safety of any specific treatment they suggest. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Drug Sensitivity Test (DST) for cancer because it offers a personalized approach to treatment. Unlike standard chemotherapy and targeted therapies that often follow a one-size-fits-all model, DST uses genomic screening to pinpoint which drugs a specific patient's cancer cells are sensitive or resistant to. This means treatments can be tailored to the individual's unique cancer profile, potentially improving effectiveness and reducing unnecessary side effects. By guiding physicians to the best therapy choices based on each patient's biology, DST could revolutionize how we approach cancer treatment.

What evidence suggests that Drug Sensitivity Test (DST) is effective for cancer?

Research has shown that Drug Sensitivity Testing (DST), which participants in this trial will undergo, can identify the cancer treatments most likely to be effective for each individual. It acts as a test to determine which drugs a person's cancer cells respond to best. Although DST is typically used for infections, it functions similarly for cancer. By pinpointing effective treatments, DST addresses issues like drug resistance and limited treatment options. Early studies suggest this personalized approach could improve outcomes for people with advanced cancer, particularly when other treatments have failed. ^{5 6 7 8 9}

Who Is on the Research Team?

Jorge Manrique-Succar, MD

Principal Investigator

Lerner College of Medicine, Cleveland Clinic Florida

Diana Azzam, PhD

Principal Investigator

Robert Stempel College of Public Health and Social Work, Florida International University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recurrent or refractory cancer who've tried at least two previous therapies. They must be willing to provide consent, have a recent biopsy or bone marrow sample, and agree to genetic testing. It's not for those with new, highly curable cancers or insufficient tissue samples.

Inclusion Criteria

I am willing to provide a blood sample or cheek swab for genetic testing.

Participants willing to sign informed consent

I have undergone at least two previous treatments.

Exclusion Criteria

There wasn't enough of my cancer tissue removed for further testing.

I do not have accessible cancerous tissue for testing.

My newly diagnosed tumor is highly curable with standard treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Drug Sensitivity Testing

Participants undergo drug sensitivity testing and genomic screening to inform treatment decisions

4 weeks

Treatment Recommendation

Feasibility of providing treatment recommendations based on ex vivo drug sensitivity testing

Up to 4 weeks

Follow-up

Participants are monitored for progression-free survival and treatment responsiveness

Up to 1 year post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Drug Sensitivity Test (DST)

Trial Overview

The study tests an individualized treatment approach using Drug Sensitivity Tests (DST) on participants' tumor samples to find the most effective therapy tailored to their specific cancer profile.

How Is the Trial Designed?

Group I: Drug Sensitivity Testing Experimental Treatment 1 Intervention

The results of the DST and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Florida International University

Collaborator

Trials

114

Recruited

19,400+

Community Foundation of Broward

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

In a review of 12 prospective studies involving 506 cancer patients, chemotherapy selected through in vitro drug sensitivity testing (DST) showed a higher mean response rate of 27% compared to 18% for empiric chemotherapy regimens.

While some studies suggested that in vitro-selected chemotherapy might lead to longer survival in certain cases, the overall impact on survival remains unclear, as only one third of patients in the trials received the in vitro-selected treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the efficacy of individualized chemotherapy selected by in vitro drug sensitivity testing for patients with cancer. Cortazar, P., Johnson, BE.[2022]

Recent studies indicate that individualized tumor response tests, especially the ATP-based chemosensitivity assay, can enhance treatment response and potentially improve survival rates in ovarian cancer patients.

While most tumor response tests correlate well with clinical resistance, their ability to predict sensitivity varies; however, molecular assays using multiple gene signatures show promise for future applications in ovarian cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemosensitivity and chemoresistance testing in ovarian cancer. Cree, IA.[2015]

Drug sensitivity testing (DST) for cancer treatment has significantly advanced in the last 20 years, allowing for faster and more sensitive testing with fewer tumor cells, which can analyze over 500 samples at a time.

These advancements in DST technology aim to improve drug selection for diverse tumor types and complex therapeutic situations, potentially leading to better outcomes for cancer patients by addressing issues like drug resistance and tumor heterogeneity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Sensitivity Testing for Cancer Therapy, Technique Analysis and Trends. Lu, DY., Lu, TR.[2023]

The collagen-gel droplet embedded culture drug sensitivity test (CD-DST) successfully evaluated chemosensitivity in 24 patients with Dukes B and C colorectal cancer, with a high success rate of 87.5% for obtaining primary tumor cell cultures.

CD-DST showed varying efficacy rates for five anticancer drugs, with adriamycin being the most effective at 60.4%, indicating its potential as a useful tool for personalizing chemotherapy treatment in colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vitro chemosensitivity test for colorectal cancer using collagen-gel droplet embedded cultures. Araki, Y., Isomoto, H., Matsumoto, A., et al.[2019]

A novel strategy using primary cultures from plexiform neurofibromas demonstrated that individualized drug testing can effectively measure the responses of tumor and nontumor cells to cytotoxic drugs like nilotinib and imatinib.

The study found that drug responses varied significantly between different tumor samples, highlighting the potential for personalized cancer treatment based on individual tumor characteristics, although further development is needed for practical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical assessment of the anticancer drug response of plexiform neurofibroma tissue using primary cultures. Jiang, W., Mautner, VF., Friedrich, RE., et al.[2020]

The study evaluated different assays for drug sensitivity testing in ovarian cancer cells, finding that the sulforhodamine-B (SRB) assay was the most consistent and sensitive for predicting responses to cisplatin and paclitaxel.

While many assays showed better predictions of drug resistance, further research is needed to establish a reliable correlation between in vitro results and actual patient responses in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of cell proliferation and cell death based assays in chemosensitivity testing. Gerçel-Taylor, C., Ackermann, MA., Taylor, DD.[2019]

In a study of 53 patients with advanced gastric cancer, HER2 expression was found to be a strong predictor of positive response to mFOLFOX7 neoadjuvant chemotherapy, with an 83.33% response rate in HER2-positive patients compared to 43.90% in HER2-negative patients.

Conversely, P53 expression was associated with a lower response rate, as P53-positive patients had a response rate of only 35.71%, while P53-negative patients had a much higher rate of 72.0%. This suggests that HER2 and P53 can help identify which patients are more likely to benefit from this chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The predictors of response to neoadjuvant chemotherapy in patients with locally advanced gastric cancer. Qu, J., Qu, X.[2022]

The collagen gel droplet-embedded culture drug-sensitivity test (CD-DST) shows over 75% accuracy in predicting patient responses to anticancer agents, suggesting it can effectively guide treatment decisions.

Patients whose cancer responds to chemotherapy based on CD-DST results tend to have longer survival times, indicating that this method may help identify effective treatments and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagen gel droplet-embedded culture drug-sensitivity test and potential for personalizing cancer treatment. Kawamura, M.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9024665/

Antimicrobial Susceptibility Testing: A Comprehensive Review ...

This article reviews common antimicrobial susceptibility testing (AST) methods and relevant issues concerning the advantages and disadvantages of each method.

2.

ann-clinmicrob.biomedcentral.com

ann-clinmicrob.biomedcentral.com/articles/10.1186/s12941-024-00703-5

Investigation of antimicrobial susceptibility patterns, risk ...

This study aimed to investigate the microbial spectrum, antimicrobial resistance patterns, risk factors, and their impact on clinical outcomes in these ...

3.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK539714/

Antimicrobial Susceptibility Testing - StatPearls - NCBI - NIH

Antimicrobial susceptibility testing is a laboratory procedure performed by medical technologists (clinical laboratory scientists) to identify which ...

4.

academic.oup.com

academic.oup.com/jac/article/79/Supplement_1/i13/7762028

Evaluating the impact of rapid antimicrobial susceptibility ...

This article reviews various metrics that have been described in the literature to measure the impact of rapid AST on actionability, antibiotic exposure and ...

5.

fda.gov

fda.gov/drugs/development-resources/antibacterial-susceptibility-test-interpretive-criteria

Antibacterial Susceptibility Test Interpretive Criteria

This web page provides information about the in vitro susceptibility of bacteria to certain drugs. The safety and efficacy of these drugs in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11210011/

Investigation of antimicrobial susceptibility patterns, risk ...

This study aimed to investigate the microbial spectrum, antimicrobial resistance patterns, risk factors, and their impact on clinical outcomes in these ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12081381/

Advancements in AI-driven drug sensitivity testing research

This article provides a comprehensive overview of the advancements in research concerning pathogen AST and resistance detection methodologies, ...

8.

accpjournals.onlinelibrary.wiley.com

accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.2781

Antimicrobial susceptibility testing: An updated primer for ...

This updated primer serves to reinforce important principles of AST, and to provide guidance on their implementation and optimization.

9.

tldrpharmacy.com

tldrpharmacy.com/content/what-every-pharmacist-should-know-about-antimicrobial-susceptibility-testing

What Every Pharmacist Should Know about Antimicrobial ...

Antimicrobial susceptibility testing (AST) is probably the single most important activity performed in the clinical microbiology laboratory.