Pazopanib Hydrochloride in Treating Young Patients With Solid Tumors That Have Relapsed or Not Responded to Treatment

Completed · Phase 1

Conditions studied: Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Embryonal Tumor, Childhood Central Nervous System Germ Cell Tumor, Childhood Central Nervous System Germinoma, Childhood Central Nervous System Mixed Germ Cell Tumor, Childhood Central Nervous System Teratoma, Childhood Central Nervous System Yolk Sac Tumor, Metastatic Childhood Soft Tissue Sarcoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Central Nervous System Embryonal Tumor, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Visual Pathway Glioma, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of pazopanib hydrochloride in treating young patients with solid tumors that have relapsed or not responded to treatment. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key facts

Study ID

NCT00929903

Run by

National Cancer Institute (NCI)

People needed

55

Starts

2009-06-01

Last updated by the study team

2013-09-30

Who can join

Age: 2 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following:
• NOTE: Histologic confirmation not required for intrinsic brain stem cell tumor, optic pathway gliomas, pineal tumors and elevations of cerebrospinal fluid, and serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin.
• Histologically confirmed relapsed or refractory solid tumors at original diagnosis including CNS tumors* (Part 1 and Part 2a)
• Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥ 1 week
• Histologically confirmed soft tissue sarcoma, desmoplastic small round cell tumor, or extraosseus Ewing sarcoma at original diagnosis including the following (Part 2b):
• Tumor in the head, neck, or extremity or fixed within the abdomen or pelvis that it is not sensitive to motion artifact
• No isolated pulmonary metastases
• Disease with no known curative therapy or no therapy proven to prolong survival with acceptable quality of life
• Measurable or evaluable disease (Part 1 and Part 2a)
• Measurable tumor that is ≥ 2 cm in its longest diameter (Part 2b)
• Patients must be:
• > 2 years of age and ≤ 21 years of age (Part 1 and Part 2a)
• > 2 years of age and ≤ 25 years of age (Part 2b)
• Body surface area ≥ 0.48 m\^2 (Part 1 and Part 2b)
• For patients with CNS tumors or CNS metastasis, there must be no evidence of new CNS hemorrhage of more than punctate size and/or > 3 foci of punctate hemorrhage on baseline MRI for primary CNS tumors ≥ 14 days prior to study entry
• Karnofsky performance status (PS) 50-100% (> 16 years of age)
• Lansky PS 50-100% (≤ 16 years of age)
• Platelet count ≥ 100,000/mm\^3 (transfusion independent)
• ANC ≥ 1,000/mm\^3
• Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
• 0.6 mg/dL (1 to < 2 years of age)
• 0.8 mg/dL (2 to < 6 years of age)
• 1 mg/dL (6 to < 10 years of age)
• 1.2 mg/dL (10 to < 13 years of age)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• Columbia University Medical Center — New York, 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
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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