Recruitment

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