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Kinase Inhibitor
Efficacy Phase Arm B (cabozantinib, MAP) for Osteosarcoma
Phase 2 & 3
Waitlist Available
Led By Michael W Bishop
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a drug (cabozantinib) combined with 3 chemo drugs (methotrexate, doxorubicin, cisplatin) can treat newly diagnosed osteosarcoma better than chemo alone.
Eligible Conditions
- Osteosarcoma
- Bone Sarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-free survival (EFS) (Phase II)
Event-free survival (EFS) (Phase III)
Occurrence of dose-limiting toxicity (DLT) (Feasibility)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Feasibility phase (cabozantinib, MAP)Experimental Treatment9 Interventions
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.
Group II: Efficacy Phase Arm D (cabozantinib, MAP)Experimental Treatment8 Interventions
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. Patients also undergo X-ray, CT, MRI, and 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.
Group III: Efficacy Phase Arm B (cabozantinib, MAP)Experimental Treatment9 Interventions
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. Patients also undergo X-ray, CT, MRI, and 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.
Group IV: Efficacy Phase Arm A (MAP)Active Control8 Interventions
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. Patients also undergo X-ray, CT, MRI, and 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.
Group V: Efficacy Phase Arm C (MAP)Active Control8 Interventions
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. Patients also undergo X-ray, CT, MRI, and 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Cabozantinib S-malate
2013
Completed Phase 2
~470
Bone Scan
2015
Completed Phase 2
~50
Surgical Procedure
2020
Completed Phase 2
~160
Cisplatin
2013
Completed Phase 3
~3120
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Methotrexate
2019
Completed Phase 4
~4400
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,019,815 Total Patients Enrolled
104 Trials studying Osteosarcoma
15,418 Patients Enrolled for Osteosarcoma
Michael W BishopPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be younger than 40 years old when you join the study.You need to be a certain size to participate, which means you must have a body surface area of at least 0.8 square meters.The study is in the later stages of testing to determine if the treatment works.You have cancer that has spread to other parts of your body, but your main tumor can still be surgically removed.You have cancer that has spread to your brain.You are taking certain medications that prevent blood clotting.You have a history of a severe wound or a broken bone that has not healed properly.You have cancer that has spread to other parts of your body and a tumor that can be surgically removed. A team of doctors will decide if your tumor can be removed.Your heart is healthy enough to participate in the study, based on certain standards.You cannot swallow pills.You are currently taking part in another research study that is not part of this one.You have cancer that has spread to your lungs, as confirmed by a biopsy or imaging showing one or more lesions that are at least 5mm in size, or multiple lesions that are 3mm or larger.You have a type of bone cancer called osteosarcoma that started in a bone other than your pelvis. Your medical team thinks they can remove the cancer with surgery and they haven't found any signs that it has spread elsewhere in your body.You are a nursing mother who intends to breastfeed.You have been diagnosed with high grade osteosarcoma by a doctor. This can be a primary tumor located in any part of your body. If you have had osteosarcoma before, you can still participate as long as you have not received chemotherapy treatment for it.Cancer cells have spread to other areas of your body, except for nearby lymph nodes or bones close to the main tumor. If cancer cells have spread to a bone next to the main tumor, it is considered a bone metastasis.You have a cancerous tumor in your pelvis that cannot be removed by surgery or has spread to other parts of your body according to imaging tests.Patients with cancer that has spread to other parts of the body, as well as those with cancer in one spot, can participate.You have received treatment for osteosarcoma or any other type of cancer in the past.You have a gastrointestinal disorder that could cause a hole or abnormal connection in your digestive tract.You have a medical or surgical condition that could affect how your body absorbs cabozantinib in your stomach and intestines.You have had an allergic reaction or are sensitive to any of the ingredients in the study treatment.If you have possible bone metastases based on a PET scan, you need to have a biopsy or additional imaging, such as an MRI or CT scan, to confirm.
Research Study Groups:
This trial has the following groups:- Group 1: Efficacy Phase Arm A (MAP)
- Group 2: Efficacy Phase Arm B (cabozantinib, MAP)
- Group 3: Efficacy Phase Arm C (MAP)
- Group 4: Efficacy Phase Arm D (cabozantinib, MAP)
- Group 5: Feasibility phase (cabozantinib, MAP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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