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Spots Global Cancer Trial Database for A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

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Trial Identification

Brief Title: A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

Official Title: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination With Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

Study ID: NCT05691478

Study Description

Brief Summary: This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to standard MAP (high dose methotrexate, doxorubicin hydrochloride \[doxorubicin\], and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor. II. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with localized, resectable osteosarcoma. III. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with metastatic, pelvic and unresectable osteosarcoma. SECONDARY OBJECTIVES: I. To determine whether MAP chemotherapy plus cabozantinib results in more favorable overall survival (OS) than MAP chemotherapy alone in patients with localized, resectable osteosarcoma. II. To determine whether MAP chemotherapy plus cabozantinib results in more favorable overall survival (OS) than MAP chemotherapy alone in patients with metastatic, pelvic and unresectable osteosarcoma. EXPLORATORY OBJECTIVES: I. To determine the rate of good histologic response (\> 90%) of resected primary tumor specimens following neoadjuvant chemotherapy with MAP plus cabozantinib and compare with response rates for MAP chemotherapy alone. II. To describe the toxicities of the addition of cabozantinib to MAP chemotherapy in patients with newly diagnosed osteosarcoma. III. To describe frequency of application of local control methods (surgery, hypofractionated stereotactic body radiotherapy, or radiofrequency ablation) for extrapulmonary metastatic osteosarcoma. IV. To compare total cumulative delivered doses of MAP chemotherapy agents between standard and experimental arms across multiple phases of therapy. V. To assess the pharmacokinetics of cabozantinib when administered concomitantly with standard chemotherapy agents during feasibility. VI. To collect pulmonary metastatic lesions, paired primary tumor tissue, and serial blood samples for tumor profiling, liquid biopsies, and future testing of correlative biology studies. OUTLINE: This is a dose-escalation study of cabozantinib (Feasibility Phase) followed by a randomized phase II/III study (Efficacy Phase). FEASIBILITY PHASE: Patients receive cabozantinib orally (PO), methotrexate intravenously (IV), doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles. Patients are then considered for appropriate local control. Then they receive "consolidation" with methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day cycle, followed by cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day cycle, and cabozantinib PO, methotrexate IV, and doxorubicin IV for two 35-day cycles. Patients then receive cabozantinib PO for six 28-day "maintenance" cycles. EFFICACY PHASE: Patients with standard risk osteosarcoma are randomized to Arm A or Arm B. Patients with high risk osteosarcoma are randomized to Arm C or Arm D. ARM A: Standard risk patients receive methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by appropriate local control. Patients then receive "consolidation" with methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day cycles and methotrexate IV and doxorubicin IV for two additional 35-day cycles. ARM B: Standard risk patients receive cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by appropriate local control. Patients then receive "consolidation" with cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "consolidation" cycles, and cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional 35-day cycles. Patients then receive cabozantinib PO for six 28-day "maintenance" cycles. ARM C: High risk patients receive methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by appropriate local control. Patients then receive "consolidation" with methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day cycles and methotrexate IV and doxorubicin IV for two additional 35-day cycles. ARM D: High risk patients receive cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by appropriate local control. Patients then receive "consolidation" with methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day cycle, followed by cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day cycle and cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional 35-day cycles. Patients then receive cabozantinib PO for six 28-day "maintenance" cycles. All patients also undergo X-ray, computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) or bone scintigraphy at diagnosis and additonal time points throughout the trial. All patients also undergo collection of blood samples during screening and on study.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

Arkansas Children's Hospital, Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Loma Linda University Medical Center, Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States

Valley Children's Hospital, Madera, California, United States

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

Kaiser Permanente-Oakland, Oakland, California, United States

Children's Hospital of Orange County, Orange, California, United States

Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States

Rady Children's Hospital - San Diego, San Diego, California, United States

UCSF Medical Center-Mission Bay, San Francisco, California, United States

Alfred I duPont Hospital for Children, Wilmington, Delaware, United States

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States

Nicklaus Children's Hospital, Miami, Florida, United States

AdventHealth Orlando, Orlando, Florida, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

Northwestern University, Chicago, Illinois, United States

Riley Hospital for Children, Indianapolis, Indiana, United States

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Norton Children's Hospital, Louisville, Kentucky, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

Maine Children's Cancer Program, Scarborough, Maine, United States

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Children's Hospital of Michigan, Detroit, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States

Summerlin Hospital Medical Center, Las Vegas, Nevada, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Morristown Medical Center, Morristown, New Jersey, United States

Newark Beth Israel Medical Center, Newark, New Jersey, United States

Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States

Albany Medical Center, Albany, New York, United States

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

NYU Langone Hospital - Long Island, Mineola, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

New York Medical College, Valhalla, New York, United States

Duke University Medical Center, Durham, North Carolina, United States

East Carolina University, Greenville, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Dayton Children's Hospital, Dayton, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Oregon Health and Science University, Portland, Oregon, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Prisma Health Richland Hospital, Columbia, South Carolina, United States

Saint Francis Hospital, Greenville, South Carolina, United States

BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States

Saint Francis Cancer Center, Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

The Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Dell Children's Medical Center of Central Texas, Austin, Texas, United States

Medical City Dallas Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

El Paso Children's Hospital, El Paso, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

M D Anderson Cancer Center, Houston, Texas, United States

Covenant Children's Hospital, Lubbock, Texas, United States

UMC Cancer Center / UMC Health System, Lubbock, Texas, United States

Children's Hospital of San Antonio, San Antonio, Texas, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Primary Children's Hospital, Salt Lake City, Utah, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Children's Hospital of The King's Daughters, Norfolk, Virginia, United States

VCU Massey Cancer Center at Stony Point, Richmond, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Seattle Children's Hospital, Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

Contact Details

Name: Michael W Bishop

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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