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Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD

Primary Purpose

Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FoundationOne Liquid CDx
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ewing Sarcoma focused on measuring Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue, Peripheral Primitive Neuroectodermal Tumor, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissue, High-grade osteosarcoma

Eligibility Criteria

12 Months - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: For Part A, subjects must meet all of the following eligibility criteria. Age: ≥ 12 months of age at time of study enrollment to 50 years of age Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, localized or regionally disseminated Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue or; Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, non-pelvic, localized or regionally disseminated high-grade osteosarcoma. NOTE: Staging will be assessed according to standard of care at the treating center. Prior Therapy: Patients should have only previously had a biopsy, and not had prior attempt at tumor resection. Not yet started chemotherapy or radiation therapy OR patient has started chemotherapy or radiation therapy, but an appropriate pre-treatment baseline sample was collected and processed for ctDNA under a local banking study in DFCI Pediatrics and is available to use for this study. Planned to receive chemotherapy as follows: -- VDC/IE as per COG protocols AEWS0031, AEWS1031 or AEWS1221 (for patients with Ewing sarcoma or PNET); or MAP as per COG protocol AOST0331 (for patients with osteosarcoma). For Part B subjects must meet all of the following eligibility criteria. Age: ≥ 12 months of age at time of study enrollment Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue Prior Therapy: Patients should have had only frontline therapy as per institutional standard, and maintenance therapy if given (no relapse therapy). If frontline systemic therapy already completed (not including maintenance or metastatic site radiation), therapy completed within 6 months of enrollment to Part B. Subjects must have a willing physician provider supporting their participation in Part B. For Part B, providers are eligible to receive the provider survey if they are listed as the primary provider for the patient at the study site. Exclusion Criteria: For Part A, subjects must not meet any of the following exclusion criteria. Patients with distant metastatic disease. Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible. Patients who are enrolled with an initial diagnosis of Ewing sarcoma and subsequently found to have Ewing-like sarcoma will be replaced. Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol. Patients weighing < 5 kg at time of diagnosis Patients with a second malignant neoplasm Patients without detectable tumor at the time of study enrollment (ie, complete tumor resection prior to study enrollment) Patients already receiving tumor-directed therapy at the time of study enrollment except when a pre-treatment baseline sample has already been obtained under a local banking study in DFCI Pediatrics that would be eligible for analysis under this study. Patients with osteosarcoma with a pelvic primary tumor site Pregnancy For Part B, subjects must not meet any of the following exclusion criteria. Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible. Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol Patients weighing < 5 kg at time of enrollment Patients diagnosed with relapsed disease and/or having started therapy directed at disease relapse Pregnancy Resides outside of the United States For Part B, providers at non-study centers will not be eligible to receive the provider survey.

Sites / Locations

  • Childrens Hospital Los AngelesRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Massachusetts General Hospital Cancer CenterRecruiting
  • Boston Children's HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Children's Hospital's and Clinics of MinnesotaRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Nationwide Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Lifespan / Rhode Island HospitalRecruiting
  • St. Jude Children's Research HospitalRecruiting
  • UT Southwestern Medical CenterRecruiting
  • University of Utah Childrens Medical CenterRecruiting
  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

REG EWING or OSTEO: ctDNA EVALUATION

EWING ctDNA RETURN OF RESULTS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Event-free survival rate
Proportion of patient without an event by baseline detection of ctDNA

Secondary Outcome Measures

Event-free survival rate
Proportion of patient without an event by ctDNA burden at baseline

Full Information

First Posted
September 28, 2023
Last Updated
October 5, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Alex's Lemonade Stand Foundation, Conquer Cancer Foundation, Harvard University, Sam Day Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT06068075
Brief Title
Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD
Official Title
Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: The LEOPARD Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Alex's Lemonade Stand Foundation, Conquer Cancer Foundation, Harvard University, Sam Day Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma.
Detailed Description
The purpose of this study is to evaluate whether ctDNA in the blood can provide information about the chances of Ewing sarcoma or osteosarcoma coming back after treatment. This research study is evaluating a new advanced laboratory test to detect small pieces of tumor genes in the peripheral blood known as circulating tumor DNA (ctDNA). Part A : During this part of the research study (Part A) participants will be asked to provide blood samples at pre-defined times. These blood samples may help find specific genetic alterations commonly seen in Ewing sarcoma or osteosarcoma that may allow investigators to learn more about the uses of ctDNA. The results of the ctDNA analysis will not be returned to participants. Approximately 90 patients will take part in this study across multiple centers. Part B: This research study is evaluating new advanced laboratory tests to detect small pieces of tumor genes in the peripheral blood known as circulating tumor DNA (ctDNA). Part B of the research study, which focuses on ctDNA tests that can be returned to providers and patients with Ewing sarcoma. This part of the study will allow comparison of commercial ctDNA testing from Foundation Medicine to our research testing. It is expected that about 60 people with Ewing sarcoma will take part in Part B of this research study. The sponsor of this protocol is Dana-Farber Cancer Institute and is providing funding for the study. Additional funding for this study is provided by the Conquer Cancer Foundation of the American Society of Clinical Oncology, Alex's Lemonade Stand Foundation, Boston Children's Hospital Office of Faculty Development, the Friends of Dana-Farber Cancer Institute, The Harvard Catalyst Program, and the Spada Pediatric Sarcoma Foundation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue, Peripheral Primitive Neuroectodermal Tumor, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissue, High-grade Osteosarcoma
Keywords
Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue, Peripheral Primitive Neuroectodermal Tumor, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissue, High-grade osteosarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REG EWING or OSTEO: ctDNA EVALUATION
Arm Type
No Intervention
Arm Description
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
Arm Title
EWING ctDNA RETURN OF RESULTS
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
FoundationOne Liquid CDx
Other Intervention Name(s)
Liquid Biopsy
Intervention Description
a FoundationOne liquid biopsy test kit will be sent to the laboratory of the subject's treating center, in addition to the paired cell stabilizing tube from the primary center
Primary Outcome Measure Information:
Title
Event-free survival rate
Description
Proportion of patient without an event by baseline detection of ctDNA
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Event-free survival rate
Description
Proportion of patient without an event by ctDNA burden at baseline
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For Part A, subjects must meet all of the following eligibility criteria. Age: ≥ 12 months of age at time of study enrollment to 50 years of age Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, localized or regionally disseminated Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue or; Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, non-pelvic, localized or regionally disseminated high-grade osteosarcoma. NOTE: Staging will be assessed according to standard of care at the treating center. Prior Therapy: Patients should have only previously had a biopsy, and not had prior attempt at tumor resection. Not yet started chemotherapy or radiation therapy OR patient has started chemotherapy or radiation therapy, but an appropriate pre-treatment baseline sample was collected and processed for ctDNA under a local banking study in DFCI Pediatrics and is available to use for this study. Planned to receive chemotherapy as follows: -- VDC/IE as per COG protocols AEWS0031, AEWS1031 or AEWS1221 (for patients with Ewing sarcoma or PNET); or MAP as per COG protocol AOST0331 (for patients with osteosarcoma). For Part B subjects must meet all of the following eligibility criteria. Age: ≥ 12 months of age at time of study enrollment Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue Prior Therapy: Patients should have had only frontline therapy as per institutional standard, and maintenance therapy if given (no relapse therapy). If frontline systemic therapy already completed (not including maintenance or metastatic site radiation), therapy completed within 6 months of enrollment to Part B. Subjects must have a willing physician provider supporting their participation in Part B. For Part B, providers are eligible to receive the provider survey if they are listed as the primary provider for the patient at the study site. Exclusion Criteria: For Part A, subjects must not meet any of the following exclusion criteria. Patients with distant metastatic disease. Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible. Patients who are enrolled with an initial diagnosis of Ewing sarcoma and subsequently found to have Ewing-like sarcoma will be replaced. Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol. Patients weighing < 5 kg at time of diagnosis Patients with a second malignant neoplasm Patients without detectable tumor at the time of study enrollment (ie, complete tumor resection prior to study enrollment) Patients already receiving tumor-directed therapy at the time of study enrollment except when a pre-treatment baseline sample has already been obtained under a local banking study in DFCI Pediatrics that would be eligible for analysis under this study. Patients with osteosarcoma with a pelvic primary tumor site Pregnancy For Part B, subjects must not meet any of the following exclusion criteria. Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible. Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol Patients weighing < 5 kg at time of enrollment Patients diagnosed with relapsed disease and/or having started therapy directed at disease relapse Pregnancy Resides outside of the United States For Part B, providers at non-study centers will not be eligible to receive the provider survey.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David S. Shulman, MD
Phone
617-632-6670
Email
david_shulman@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Shulman, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edwin Choy, MD
Email
echoy@partners.org
First Name & Middle Initial & Last Name & Degree
Edwin Choy, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Shulman, MD
Phone
617-632-6670
First Name & Middle Initial & Last Name & Degree
David Shulman, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pricilla Merriam, MD
Phone
617-632-5204
First Name & Middle Initial & Last Name & Degree
Pricilla Merriam, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David S Shulman, MD
Phone
617-632-6670
Email
david_shulman@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
David S Shulman, MD
Facility Name
Children's Hospital's and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kris Ann Schultz
First Name & Middle Initial & Last Name & Degree
Kris Ann Schultz, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Turpin, MD
First Name & Middle Initial & Last Name & Degree
Brian Turpin, MD
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhuvana Setty, MD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Bagatell, MD
First Name & Middle Initial & Last Name & Degree
Rochelle Bagatell, MD
Facility Name
Lifespan / Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley DeNardo, MD
First Name & Middle Initial & Last Name & Degree
Bradley DeNardo, MD
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bishop, MD
First Name & Middle Initial & Last Name & Degree
Michael Bishop, MD
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avanthi Shah, MD
First Name & Middle Initial & Last Name & Degree
Avanthi Shah, MD
Facility Name
University of Utah Childrens Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Maese, MD
First Name & Middle Initial & Last Name & Degree
Luke Maese, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Hawkins, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD

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