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

Trial Summary

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 data supports the effectiveness of the drug sensitivity test (DST) for cancer treatment?

Research shows that drug sensitivity testing (DST) can accurately predict how well cancer treatments will work, with one method showing over 75% accuracy in matching test results to actual patient responses. This suggests that DST can help identify which patients are likely to benefit from specific cancer drugs, potentially leading to longer survival times. ^{1 2 3 4 5}

Is Drug Sensitivity Testing (DST) safe for humans?

The research articles do not provide specific safety data for Drug Sensitivity Testing (DST) in humans, focusing instead on its effectiveness in predicting chemotherapy responses. ^{2 3 6 7 8}

How is the Drug Sensitivity Test (DST) treatment different from other cancer treatments?

The Drug Sensitivity Test (DST) is unique because it personalizes cancer treatment by testing how a patient's tumor cells respond to different drugs before starting therapy, similar to how antibiotics are chosen based on sensitivity tests for infections. This approach aims to select the most effective drug for each individual, potentially improving outcomes compared to standard treatments that do not consider individual tumor responses. ^{1 2 3 4 6}

What is the purpose of this trial?

A personalized cancer medicine approach would address therapy resistance, cancer metastasis, and limited options after standard of care is exhausted in advanced cancer participants. This approach may reduce the barriers to approved therapeutic assignment currently limited to a particular cancer type or patient demographic.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Preclinical assessment of the anticancer drug response of plexiform neurofibroma tissue using primary cultures. [2020]

2. Greece pubmed.ncbi.nlm.nih.gov

Evaluation of cell proliferation and cell death based assays in chemosensitivity testing. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Chemosensitivity and chemoresistance testing in ovarian cancer. [2015]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Japan pubmed.ncbi.nlm.nih.gov

An in vitro chemosensitivity test for colorectal cancer using collagen-gel droplet embedded cultures. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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