a study on Solid Neoplasm Thyroid Gland Medullary Carcinoma Central Nervous System Neoplasm Malignant Solid Neoplasm Melanoma Skin Cancer/Melanoma Thyroid Gland Carcinoma Refractory Malignant Solid Neoplasm Solid Tumor
This phase I trial studies the side effects and best dose of cabozantinib S-malate in treating younger patients with solid tumors that have come back or no longer respond to treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
A Phase 1 Study of XL184 (Cabozantinib) in Children and Adolescents With Recurrent or Refractory Solid Tumors, Including CNS Tumors
I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of XL184 (cabozantinib) (cabozantinib S-malate) administered orally to children with refractory solid tumors including central nervous system (CNS) tumors.
II. To define and describe the toxicities of XL184 (cabozantinib) administered on this schedule.
III. To characterize the pharmacokinetics of XL184 (cabozantinib) in children with refractory solid tumors.
I. To preliminarily define the antitumor activity of XL184 (cabozantinib) within the confines of a phase 1 study.
II. To assess the biologic activity of XL184 (cabozantinib). III. To assess the biomarker response (carcinoembryonic antigen [CEA] and calcitonin) in patients with medullary thyroid cancer treated with XL184.
IV. To evaluate overall survival from study entry through a five-year follow-up period.
OUTLINE: This is a dose-escalation study. (Complete as of 4/16/2014)
Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-28. Courses 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, 6 months, and then annually for up to 60 months.
Childhood Solid Neoplasm Childhood Thyroid Gland Medullary Carcinoma Recurrent Childhood Central Nervous System Neoplasm Recurrent Malignant Solid Neoplasm Recurrent Melanoma Recurrent Thyroid Gland Carcinoma Refractory Malignant Solid Neoplasm
Open to people ages 2–18
= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
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