Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Blastic Phase, Childhood Acute Promyelocytic Leukemia With PML-RARA, Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Childhood Solid Neoplasm, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Juvenile Myelomonocytic Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Disease

In brief

This phase I/II trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Key facts

Study ID

NCT01445080

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2006-05-30

Expected to finish

2012-12-10

Last updated by the study team

2021-02-02

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following:
• Histologically confirmed malignant solid tumor at original diagnosis or relapse
• Measurable or evaluable disease by CT scan or MRI
• Histologically confirmed leukemia, including 1 of the following:
• Acute lymphoblastic leukemia (ALL)
• Greater than 25% blasts in the bone marrow (M3 bone marrow)
• Acute myeloid leukemia (AML)
• Greater than 25% blasts in the bone marrow (M3 bone marrow)
• AML and FLT3-ITD mutation
• Patients must have ? 5% blasts in the bone marrow
• Active extramedullary disease (except leptomeningeal disease) allowed
• Juvenile myelomonocytic leukemia (JMML) meeting the following criteria:
• Peripheral blood monocytosis > 1,000/mm\^3
• Blasts (including promonocytes) are < 20% of the WBCs in the blood and of the nucleated bone marrow cells
• No Philadelphia chromosome (Ph) or BCR/ABL fusion gene
• Has ? 2 of the following additional diagnostic criteria:
• Hemoglobin F increased for age
• Immature granulocytes in the peripheral blood
• WBC > 10,000/mm\^3
• Clonal chromosomal abnormality (e.g., may be monosomy 7)
• Sargramostim (GM-CSF) hypersensitivity of myeloid progenitors in vitro
• Chronic myelogenous leukemia (CML) in blast crisis
• Greater than 25% blasts in the bone marrow (M3 bone marrow)
• Patients with Ph-positive CML must be refractory to imatinib mesylate
• Relapsed or refractory disease

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University/Herbert Irving Cancer Center — New York, New York, United States
• State University of New York Upstate Medical University — Syracuse, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
• Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Hospital for Sick Children — Toronto, Ontario, Canada
• Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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