Precision Medicine for Metastatic Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Good Samaritan Hospital Medical Center, New York

Disqualifiers: Pregnancy, Severe cardiac, Pulmonary, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems that the decision on medication use will be made by your treating oncologist based on the precision medicine testing results.

What data supports the effectiveness of the drug Darwin OncoTarget and OncoTreat for metastatic disease?

Research suggests that precision medicine, which uses genetic information to tailor treatments, can be effective for various cancers. Studies show that targeting specific genetic changes in tumors can lead to better outcomes, and this approach is being explored in clinical trials for metastatic diseases. ^{1 2 3 4 5}

Is the precision medicine treatment for metastatic disease safe for humans?

The available research does not provide specific safety data for the precision medicine treatment under the names Darwin OncoTarget or OncoTreat. The studies focus on genomic profiling and treatment selection, but do not report on safety outcomes. ^{6 7 8 9 10}

How does this treatment differ from other treatments for metastatic disease?

This treatment is unique because it uses precision medicine, which tailors therapy based on the genetic profile of a patient's cancer, potentially leading to more effective and individualized treatment options compared to standard therapies. ^{7 8 11 12 13}

What is the purpose of this trial?

This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.

Eligibility Criteria

This trial is for patients with oligometastasis from various solid tumors who are undergoing radiation therapy. They must have a tumor biopsy before precision medicine testing and be willing to potentially change their standard treatment based on the test results.

Inclusion Criteria

I have up to 10 brain tumors treatable with radiotherapy.

My blood, kidney, and liver tests are within safe ranges.

I am receiving radiation therapy at Good Samaritan University Hospital.

Exclusion Criteria

Patients with an estimated median survival of less than 6 months using the published and validated NEAT methodology

I am not pregnant, breastfeeding, and do not have severe heart, lung, infectious diseases or brain disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy and Testing

Mandatory tumor biopsy is performed for precision medicine testing using Darwin OncoTarget and OncoTreat

1-2 weeks

1 visit (in-person)

Radiation Therapy

Participants receive comprehensive involved site radiotherapy to all areas of visible disease

6-8 weeks

Multiple visits (in-person)

Systemic Therapy

Systemic therapy is administered based on standard of care or informed by Darwin testing

Variable, based on treatment plan

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Regular visits as per standard of care

Treatment Details

Interventions

• Darwin OncoTarget and OncoTreat

Trial Overview The trial tests OncoTarget and OncoTreat, which are precision medicine tests performed on biopsied tumor tissue. These tests aim to guide oncologists in deciding whether to continue standard care or switch to a personalized treatment plan.

Participant Groups

Group I: Feasibility Experimental Treatment 1 Intervention

All study participants will get the same study intervention. It will include the usual radiation to all areas of visible disease. Systemic therapy will be determined by your medical oncologist with the supplemental information provided by the Darwin OncoTarget and OncoTreat test.

Who Is Running the Clinical Trial?

Good Samaritan Hospital Medical Center, New York

Lead Sponsor

Trials

7

Recruited

6,900+

Findings from Research

The repository includes 79 patient-derived xenograft (PDX) models of lung cancer, primarily non-small cell lung cancer (NSCLC), which have been thoroughly characterized for their genomic and clinical features, making them a valuable resource for testing new cancer therapies.

These PDX models maintain key characteristics of the original patient tumors and demonstrate expected treatment responses, confirming their utility as reliable preclinical platforms for cancer research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Genomically and Clinically Annotated Patient-Derived Xenograft Resource for Preclinical Research in Non-Small Cell Lung Cancer. Woo, XY., Srivastava, A., Mack, PC., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Discovering novel valid biomarkers and drugs in patient-centric genomic trials: the new epoch of precision surgical oncology. [2019]

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

Integrated clinical, whole-genome, and transcriptome analysis of multisampled lethal metastatic prostate cancer. [2022]

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

Unique molecular signatures as a hallmark of patients with metastatic breast cancer: implications for current treatment paradigms. [2021]

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

From Tissue-Agnostic to N-of-One Therapies: (R)Evolution of the Precision Paradigm. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

A combined biological and clinical rationale for evaluating metastasis directed therapy in the management of oligometastatic prostate cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Challenges and opportunities associated with the MD Anderson IMPACT2 randomized study in precision oncology. [2022]

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

Clinical Use of Precision Oncology Decision Support. [2020]

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

Spontaneous genomic alterations in a chimeric model of colorectal cancer enable metastasis and guide effective combinatorial therapy. [2021]

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

A Genomically and Clinically Annotated Patient-Derived Xenograft Resource for Preclinical Research in Non-Small Cell Lung Cancer. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Precision medicine: preliminary results from the Initiative for Molecular Profiling and Advanced Cancer Therapy 2 (IMPACT2) study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The Oncology Biomarker Discovery framework reveals cetuximab and bevacizumab response patterns in metastatic colorectal cancer. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Molecular tumour board at European Institute of Oncology: Report of the first three year activity of an Italian precision oncology experience. [2023]

13. Germany pubmed.ncbi.nlm.nih.gov

[Establishment of a living biobank : Improved guidance of precision cancer care with in vitro and in vivo cancer models]. [2019]