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Clinical Trial Summary

This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults with Ewing sarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, and Wilms tumor. 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) on a continuous dosing schedule using a dosing nomogram 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. ;


Study Design


Related Conditions & MeSH terms

  • Adrenal Cortical Carcinoma
  • Adrenocortical Carcinoma
  • Alveolar Soft Part Sarcoma
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Neuroendocrine
  • Carcinoma, Renal Cell
  • Central Nervous System Neoplasm
  • Central Nervous System Neoplasms
  • Clear Cell Sarcoma of Soft Tissue
  • Ewing Sarcoma
  • Hepatoblastoma
  • Hepatocellular Carcinoma
  • Neoplasms
  • Nervous System Neoplasms
  • Osteosarcoma
  • Recurrence
  • Recurrent Alveolar Soft Part Sarcoma
  • Recurrent Ewing Sarcoma
  • Recurrent Hepatoblastoma
  • Recurrent Hepatocellular Carcinoma
  • Recurrent Kidney Wilms Tumor
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Osteosarcoma
  • Recurrent Primary Malignant Central Nervous System Neoplasm
  • Recurrent Renal Cell Carcinoma
  • Recurrent Rhabdomyosarcoma
  • Recurrent Soft Tissue Sarcoma
  • Recurrent Thyroid Gland Medullary Carcinoma
  • Refractory Ewing Sarcoma
  • Refractory Hepatoblastoma
  • Refractory Hepatocellular Carcinoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Osteosarcoma
  • Refractory Primary Central Nervous System Neoplasm
  • Refractory Primary Malignant Central Nervous System Neoplasm
  • Refractory Renal Cell Carcinoma
  • Refractory Rhabdomyosarcoma
  • Refractory Soft Tissue Sarcoma
  • Renal Cell Carcinoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Alveolar Soft Part
  • Sarcoma, Clear Cell
  • Sarcoma, Ewing
  • Soft Tissue Sarcoma
  • Solid Neoplasm
  • Thyroid Diseases
  • Thyroid Gland Medullary Carcinoma
  • Thyroid Neoplasms
  • Wilms Tumor

NCT number NCT02867592
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 18, 2017
Completion date September 21, 2024

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