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

Conditions

• Adrenal Cortical Carcinoma
• Alveolar Soft Part Sarcoma
• Central Nervous System Neoplasm
• Childhood Clear Cell Sarcoma of Soft Tissue
• Clear Cell Sarcoma of Soft Tissue
• Ewing Sarcoma
• Hepatoblastoma
• Hepatocellular Carcinoma
• Osteosarcoma
• Recurrent Adrenal Cortical Carcinoma
• Recurrent Alveolar Soft Part Sarcoma
• Recurrent Clear Cell Sarcoma of Soft Tissue
• 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 Adrenal Cortical Carcinoma
• Refractory Alveolar Soft Part Sarcoma
• Refractory Clear Cell Sarcoma of Soft Tissue
• 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
• Refractory Thyroid Gland Medullary Carcinoma
• Refractory Wilms Tumor
• Renal Cell Carcinoma
• Rhabdomyosarcoma
• Soft Tissue Sarcoma
• Solid Neoplasm
• Thyroid Gland Medullary Carcinoma
• Wilms Tumor

Eligibility Criteria

Sex

ALL

Age

2 Years - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
  Given PO
• Cabozantinib S-malate — DRUG
  Given PO Note: Capsule formulation (Cometriq) not used in this trial.
• Pharmacological Study — OTHER
  Correlative studies

Study Details

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.

Key Dates

Start date

May 18, 2017

Status verified

Dec 2025

Primary completion

Jun 30, 2021

Completion

Jun 27, 2026

Study Design

Enrollment

109 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (cabozantinib s-malate)
  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.

Primary Outcome Measure

Objective Response (Non-Osteosarcoma Strata) [ Time Frame: Up to the first 6 cycles of therapy ]

Locations (142)

Find similar trials in Birmingham, AL

Related Studies

• Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
  Enrolling By Invitation · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
• Clinical Orthopaedic Data Bank (Acute and Chronic)
  Recruiting · University of Florida · Gainesville, Florida
• Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
  Recruiting · Children's Oncology Group · Birmingham, Alabama