Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 110
Summary
- Conditions
- Clear Cell Sarcoma of Soft Tissue
- Adrenal Cortex Carcinoma
- Alveolar Soft Part Sarcoma
- Recurrent Rhabdomyosarcoma
- Central Nervous System Neoplasm
- Refractory Primary Malignant Central Nervous System Neoplasm
- Recurrent Primary Malignant Central Nervous System Neoplasm
- Recurrent Soft Tissue Sarcoma
- Childhood Clear Cell Sarcoma of Soft Parts
- Refractory Soft Tissue Sarcoma
- Ewing Sarcoma
- Recurrent Renal Cell Carcinoma
- Refractory Osteosarcoma
- Refractory Malignant Solid Neoplasm
- Recurrent Ewing Sarcoma
- Recurrent Hepatocellular Carcinoma
- Rhabdomyosarcoma
- Recurrent Malignant Solid Neoplasm
- Recurrent Thyroid Gland Medullary Carcinoma
- Hepatoblastoma
- Hepatocellular Carcinoma
- Osteosarcoma
- Renal Cell Carcinoma
- Recurrent Osteosarcoma
- Refractory Ewing Sarcoma
- Recurrent Hepatoblastoma
- Recurrent Adrenal Cortex Carcinoma
- Solid Neoplasm
- Thyroid Gland Medullary Carcinoma
- Recurrent Alveolar Soft Part Sarcoma
- Refractory Rhabdomyosarcoma
- Wilm's Tumor
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 2 years and 30 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults. II. To estimate whether XL184 therapy either improves the disease control rate at 4 months in patients with recurrent measurable osteo...
PRIMARY OBJECTIVES: I. To determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults. II. To estimate whether XL184 therapy either improves the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to a historical Childrens Oncology Group (COG) experience or produces an objective response rate. SECONDARY OBJECTIVES: I. To further define XL184 related toxicities in pediatric, adolescent and young adult patients. II. To further define XL184 pharmacokinetics in the pediatric and adolescent patients. III. To estimate 1-year time to progression, progression free survival (PFS) and overall survival for each stratum, and if feasible to compare to historical controls. EXPLORATORY OBJECTIVES: I. To assess the effect of XL184 on patients' immune cell subsets. II. To obtain tumor tissue (snap frozen, formalin-fixed and paraffin-embedded [FFPE] blocks, or unstained slides) from diagnosis, recurrence, or both, for possible future studies. OUTLINE: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 6 months for 1 year and then annually for up to 5 years.
Tracking Information
- NCT #
- NCT02867592
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Srivandana Akshintala Children's Oncology Group