Neuroectodermal Tumors > Liquid Biopsy

Liquid Biopsy for Bone Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen By David S Shulman, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must be taking: Chemotherapy

Disqualifiers: Metastatic disease, Ewing-like sarcoma, others

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a blood test that looks for small pieces of tumor DNA in patients with Ewing sarcoma or osteosarcoma. The goal is to see if this test can help predict if the cancer will return after treatment. A group of patients will participate to help researchers understand how useful this test can be.

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 mainly focuses on patients who have not yet started chemotherapy or radiation therapy, or those who have a pre-treatment sample available.

What data supports the effectiveness of the treatment FoundationOne Liquid CDx for bone cancer?

Research shows that FoundationOne Liquid CDx can identify targetable mutations in high-risk cancers, including bone sarcoma, which can guide treatment decisions. Liquid biopsies, like FoundationOne Liquid CDx, are effective in other cancers for monitoring therapy and identifying treatment targets, suggesting potential benefits for bone cancer as well.

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How is the liquid biopsy treatment for bone cancer different from other treatments?

Liquid biopsy is unique because it uses a simple blood or urine test to detect cancer-related molecules, making it less invasive and painful than traditional tissue biopsies. This approach can help monitor the cancer in real-time and guide treatment decisions without the need for surgical procedures.

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Eligibility Criteria

The LEOPARD trial is for individuals aged 12 months to 50 years with a new diagnosis of Ewing sarcoma or high-grade osteosarcoma, who have not started or just begun treatment. It's not for those with distant metastatic disease, other types of sarcomas, complete tumor resection before joining the study, pelvic primary tumors in osteosarcoma patients, or if pregnant.

Inclusion Criteria

I have received previous treatments for my condition.

I am scheduled to receive chemotherapy.

I am between 1 year and 50 years old.

Exclusion Criteria

For Part B, subjects must not meet any of the following exclusion criteria.

Resides outside of the United States

Pregnancy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: ctDNA Evaluation

Participants provide blood samples at pre-defined times to evaluate ctDNA for genetic alterations in Ewing sarcoma or osteosarcoma.

6 months

Multiple visits for blood sample collection

Part B: ctDNA Return of Results

Participants provide blood samples for ctDNA testing, with results returned to providers and patients.

6 months

Multiple visits for blood sample collection

Follow-up

Participants are monitored for event-free survival and other outcomes after the main study phases.

2 years

Participant Groups

This trial tests the use of FoundationOne Liquid CDx liquid biopsy to see how well it predicts outcomes and monitors response to therapy in patients with Ewing sarcoma or osteosarcoma. Participants will be monitored over time to assess changes in ctDNA levels.

Group I: EWING ctDNA RETURN OF RESULTS Experimental Treatment 1 Intervention

This study involves collection of blood samples at pre-specified time points as well as collection of information about this disease. For each timepoint, submit two tubes of blood (17 mL total or a little more than 3 teaspoons) to a commercial testing laboratory called Foundation Medicine and one tube of blood (10 mL or 2 teaspoons) to standard ctDNA workflow

Group II: REG EWING or OSTEO: ctDNA EVALUATION Active Control 1 Intervention

This study involves collection of blood samples at pre-specified time points as well as collection of information about this disease. For each timepoint, submit two tubes of blood (17 mL total or a little more than 3 teaspoons) per standard ctDNA workflow

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Seattle Children's Hospital Seattle, WA

Childrens Hospital Los Angeles Los Angeles, CA

Children's Healthcare of Atlanta Atlanta, GA

Massachusetts General Hospital Cancer Center Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute Lead Sponsor

Conquer Cancer Foundation Collaborator

Alex's Lemonade Stand Foundation Industry Sponsor

Harvard University Collaborator

Sam Day Foundation Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Blood-Derived Liquid Biopsies Using Foundation One&#174; Liquid CDx for Children and Adolescents with High-Risk Malignancies: A Monocentric Experience. [2022] Precision oncology requires tumor molecular profiling to identify actionable targets. Tumor biopsies are considered as the gold standard, but their indications are limited by the burden of procedures in children. Blood-derived liquid biopsy (LB) is a potential alternative that is not yet documented in real-world settings, especially in pediatric oncology. We performed a retrospective analysis of children and teenagers with a relapsing or refractory disease, upon whom LB was performed using the Foundation One® liquid CDx from 1 January 2020 to 31 December 2021 in a single center. Forty-five patients (27 boys) were included, with a median age of 9 years of age (range: 1.5-17 years old). Underlying malignancies were neuroblastoma (12 patients), bone sarcoma (12), soft tissue sarcoma (9), brain tumors (7), and miscellaneous tumors (5). Forty-three patients had metastatic disease. Six patients had more than one biopsy because of a failure in first LB. Median time to obtain results was 13 days. Overall, analysis was successful for 33/45 patients. Eight patients did not present any molecular abnormalities. Molecular alterations were identified in 25 samples with a mean of 2.1 alterations per sample. The most common alterations concerned TP53 (7 pts), EWS-FLI1 (5), ALK (3), MYC (3), and CREBBP (2). TMB was low in all cases. Six patients received treatment based on the results from LB analysis and all were treated off-trial. Three additional patients were included in early phase clinical trials. Mean duration of treatment was 85 days, with one patient with stable disease after eight months. Molecular profiling using Foundation One® Liquid CDx was feasible in pediatric patients with high-risk solid tumors and lead to identification of targetable mutations in a subset of patients.

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

Liquid biopsies in primary and secondary bone cancers. [2022] Liquid biopsies are a powerful tool to non-invasively analyze tumor phenotype and progression as well as drug resistance. In the bone oncology field, liquid biopsies would be particularly important to develop, since standard biopsies can be very painful, dangerous (e.g., when found in proximity to the spinal cord), and hard to collect. In this review, we explore the recent advances in liquid biopsies in both primary (osteosarcoma and Ewing sarcoma) and secondary bone cancers (breast, prostate, and lung cancer-induced bone metastases), presenting their current role and highlighting their unexpressed potential, as well as the barriers limiting their possible adoption, including costs, scalability, reproducibility, and isolation methods. We discuss the use of circulating tumor cells, cell-free circulating tumor DNA, and extracellular vesicles for the purpose of improving diagnosis, prognosis, evaluation of therapy resistance, and driving therapy decisions in both primary and secondary bone malignancies.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Perspective and Translational Oncology of Liquid Biopsy. [2020] The term liquid biopsy (LB) refers to the study of circulating tumor cells, circulating tumors nucleic acids free of cells or contained in exosomes, and information about platelets associated with tumors. LB can be performed in different biofluids and allows the limitations of tissue biopsy to be overcome offering possibilities of tumor identification reflecting in real time tumor heterogeneity. In addition, LB allows screening and early detection of cancer, real-time monitoring of therapy, stratification and therapeutic intervention, a therapeutic target and resistance mechanism, and a risk of metastatic relapse. Currently, LB has been shown to be effective for its application in different types of tumors including lung, colorectal, prostate, melanoma, breast and pancreatic cancer, by the determination and identification of biomarkers that with a high probability have the potential to change the way in which medical oncology could predict the course of the disease. These biomarkers make it possible to capture the heterogeneity of the cancer, monitor its clonal evolution, indicate new treatments or retreatments and evaluate the responses to different evolutionary and/or therapeutic pressures in the cancer disease.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Liquid Biopsy in Colorectal Cancer: Quo Vadis? Implementation of Liquid Biopsies in Routine Clinical Patient Care in Two German Comprehensive Cancer Centers. [2022] The use of liquid biopsies (LB) in patients with solid malignancies enables comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) and has the potential to guide therapy stratification and support disease monitoring. To examine clinical uptake of LB in a real-world setting, LB implementation was analyzed at two German cancer centers (LMU Munich and Charité - Universitätsmedizin Berlin) between 2017 and 2021, with focus on colorectal cancer (CRC) patients.

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

Liquid Biopsy in Solid Malignancy. [2023] The clinical utility of tissue biopsies in cancer management will continue to expand, especially with the evolving role of targeted therapies. "Liquid biopsy" refers to testing a patient's biofluid samples such as blood or urine to detect tumor-derived molecules and cells that can be used diagnostically and prognostically in the assessment of cancer. Many proof-of-concept and pilot studies have shown the clinical potential of liquid biopsies as diagnostic and prognostic markers which would provide a surrogate for the conventional "solid biopsy". In this review, we focus on three methods of liquid biopsy-circulating tumor cells, extracellular vesicles, and circulating tumor DNA-to provide a landscape view of their clinical applicability in cancer management and research.

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

Liquid biopsies in pediatric oncology: opportunities and obstacles. [2023] Liquid biopsies have emerged as a noninvasive alternative to tissue biopsy with potential applications during all stages of pediatric oncology care. The purpose of this review is to provide a survey of pediatric cell-free DNA (cfDNA) studies, illustrate their potential applications in pediatric oncology, and to discuss technological challenges and approaches to overcome these hurdles.

7. England pubmed.ncbi.nlm.nih.gov

Recommendations for a practical implementation of circulating tumor DNA mutation testing in metastatic non-small-cell lung cancer. [2022] Liquid biopsy (LB) is a rapidly evolving diagnostic tool for precision oncology that has recently found its way into routine practice as an adjunct to tissue biopsy (TB). The concept of LB refers to any tumor-derived material, such as circulating tumor DNA (ctDNA) or circulating tumor cells that are detectable in blood. An LB is not limited to the blood and may include other fluids such as cerebrospinal fluid, pleural effusion, and urine, among others.