Cabozantinib-S-Malate in Treating Younger Patients With Recurrent Refractory or Newly Diagnosed Sarcomas Wilms Tumor or Other Rare Tumors

  • STATUS
    Not Recruiting
  • End date
    Sep 30, 2021
  • participants needed
    146
  • sponsor
    National Cancer Institute (NCI)
Updated on 11 April 2021
ct scan
platelet count
cancer
hypertension
ascites
stroke
total body irradiation
absolute neutrophil count
amylase
metastatic disease
nitrosoureas
heart failure
electrolytes
tumor markers
measurable disease
carcinoma
tumor growth
vegf
lipase
growth factor
karnofsky performance status
arrhythmia
myocardial infarction
pleural effusion
MRI
glomerular filtration rate
international normalized ratio
serum lipase
metastasis
neutrophil count
cabozantinib
tumor cells
congestive heart failure
blood transfusion
solid tumors
tumor blood vessel
nitrosourea
seizure
chemotherapeutic agents
antineoplastic agents
antineoplastic
solid tumour
solid tumor
vascular endothelial growth factor
antibody therapy
platelet transfusion
iobenguane
pegfilgrastim
myelosuppressive chemotherapy
sarcoma
ewing's sarcoma
serum amylase
platelet transfusions
anti-cancer agents
xl184
nervous
seizure disorder
palliative radiation therapy
pleural effusions
crizotinib
cardiac arrhythmias
nephroblastoma
cabozantinib s-malate
adrenocortical carcinoma
hepatoblastoma
tivantinib
bone marrow infiltration

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.

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 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.

Details
Condition Alveolar Soft Part Sarcoma, Adenocarcinoma, Malignant neoplasm of kidney, Central Nervous System Neoplasms, Hepatoblastoma, Ewing's sarcoma, Osteosarcoma, Hereditary Neoplastic Syndrome, Renal Cell Carcinoma, HEPATIC NEOPLASM, Nephroblastoma, Rhabdomyosarcoma, Clear cell sarcoma, Sarcoma, HEPATOCELLULAR CARCINOMA, Adrenocortical carcinoma, Adult Alveolar Soft Part Sarcoma, Adult Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Renal Cell Carcinoma, Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Osteosarcoma, Adult Hepatocellular Carcinoma, Childhood Central Nervous System Neoplasm, Childhood Solid Neoplasm, Recurrent Rhabdomyosarcoma, Refractory Malignant Solid Neoplasm, Adult Soft Tissue Sarcoma, Thyroid Gland Medullary Carcinoma, Recurrent Hepatocellular Carcinoma, Recurrent Ewing Sarcoma, Recurrent Childhood Central Nervous System Neoplasm, Adult Clear Cell Sarcoma of Soft Parts, Childhood Alveolar Soft Part Sarcoma, Childhood Clear Cell Sarcoma of Soft Parts, Childhood Hepatocellular Carcinoma, Childhood Rhabdomyosarcoma, Childhood Soft Tissue Sarcoma, Recurrent Adrenal Cortex Carcinoma, Recurrent Adult Hepatocellular Carcinoma, Recurrent Alveolar Soft Part Sarcoma, Recurrent Childhood Hepatocellular Carcinoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Hepatoblastoma, Sarcoma (Pediatric), Recurrent Soft Tissue Sarcoma, Refractory Osteosarcoma, Refractory Soft Tissue Sarcoma, Refractory Ewing Sarcoma, Refractory Rhabdomyosarcoma, Recurrent Malignant Central Nervous System Neoplasm, Refractory Malignant Central Nervous System Neoplasm, MITF Positive, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Thyroid Gland Medullary Carcinoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Kidney Cancer, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Liver Cancer, Malignant Adenoma, Wilms' Tumor, Renal Cell Cancer, Hereditary Cancer Syndromes, Renal Cancer, Soft Tissue Sarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Soft Tissue Sarcoma, Excluding Rhabdomyosarcoma, Recurrent Primary Malignant Central Nervous System Neoplasm, Refractory Primary Malignant Central Nervous System Neoplasm
Treatment laboratory biomarker analysis, pharmacological study, Cabozantinib, Cabozantinib S-malate
Clinical Study IdentifierNCT02867592
SponsorNational Cancer Institute (NCI)
Last Modified on11 April 2021

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