Ewing Sarcoma Clinical Trial
Official title:
Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: The LEOPARD Study
NCT number | NCT06068075 |
Other study ID # | 18-138 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2018 |
Est. completion date | January 1, 2026 |
This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma.
Status | Recruiting |
Enrollment | 340 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Childrens Hospital Los Angeles | Los Angeles | California |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Children's Hospital's and Clinics of Minnesota | Minneapolis | Minnesota |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Lifespan / Rhode Island Hospital | Providence | Rhode Island |
United States | University of Utah Childrens Medical Center | Salt Lake City | Utah |
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Alex's Lemonade Stand Foundation, Conquer Cancer Foundation, Harvard University, Sam Day Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free survival rate | Proportion of patient without an event by baseline detection of ctDNA | 2 years | |
Secondary | Event-free survival rate | Proportion of patient without an event by ctDNA burden at baseline | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00026780 -
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
|
||
Recruiting |
NCT06094101 -
Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)
|
Phase 1/Phase 2 | |
Recruiting |
NCT06029218 -
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
|
N/A | |
Completed |
NCT00743496 -
A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma
|
Phase 1 | |
Recruiting |
NCT04337177 -
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT02945800 -
Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma
|
Phase 2 | |
Recruiting |
NCT06156410 -
Cabozantinib With Ifosfamide in Ewing's Sarcoma and Osteosarcoma
|
Phase 1 | |
Recruiting |
NCT05968768 -
To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
|
Phase 2 | |
Terminated |
NCT02536183 -
A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors
|
Phase 1 | |
Recruiting |
NCT03715933 -
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
|
Phase 1 | |
Active, not recruiting |
NCT03220035 -
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Completed |
NCT05093322 -
A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02856048 -
Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer
|
Phase 2/Phase 3 | |
Withdrawn |
NCT03880123 -
Selinexor in Combination With Ixazomib for the Treatment of Advanced Sarcoma
|
Phase 1 | |
Completed |
NCT04956198 -
Drug Sensitivity and Mutation Profiling
|
||
Recruiting |
NCT04791228 -
A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03709680 -
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05734066 -
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
|
Phase 1/Phase 2 | |
Completed |
NCT02044120 -
ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma
|
Phase 1 | |
Active, not recruiting |
NCT01807468 -
Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
|
Phase 2 |