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Sunitinib in Treating Young Patients With Refractory Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00387920
  Purpose

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib in treating young patients with refractory solid tumors.


Condition Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: sunitinib malate
Procedure: mass spectrometry
Procedure: pharmacological study
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Sunitinib Sunitinib malate Tyrosine Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Sunitinib (SU11248), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Children With Refractory Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose and recommended phase II dose [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antitumor effects [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2006
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and recommended phase II dose of sunitinib malate in pediatric patients with refractory solid tumors.
  • Determine the toxicity of this regimen in these patients.
  • Characterize the pharmacokinetics of this regimen in these patients.

Secondary

  • Determine, preliminarily, the antitumor effects of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive oral sunitinib malate once daily on days 1-28 days. Treatment repeats every 42 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of sunitinib malate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Blood is collected on days 1, 7, 14, 21, and 28 of course 1 for pharmacokinetic studies using liquid chromatography/mass spectrometry.

After completion of study treatment, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor

    • Recurrent or refractory disease
  • Measurable or evaluable disease
  • No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
  • Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity

    • Must not be refractory to red blood cell or platelet transfusions
  • Primary CNS tumors or known CNS metastases allowed
  • No known bone marrow metastatic disease
  • No tumors involving the pleural surface

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% (> 10 years of age) OR Lansky PS 50-100% (≤ 10 years of age)
  • Absolute neutrophil count ≥ 1,000/mm³*
  • Platelet count ≥ 100,000/mm³ (transfusion independent)*
  • Hemoglobin ≥ 8.0 g/dL (transfusions allowed)*
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender as follows:

    • No greater than 0.8 mg/dL (2 to 5 years of age)
    • No greater than 1 mg/dL (6 to 9 years of age)
    • No greater than 1.2 mg/dL (10 to 12 years of age)
    • No greater than 1.5 mg/dL (male) OR 1.4 mg/dL (female) (13 to 15 years of age)
    • No greater than 1.7 mg/dL (male) OR 1.4 mg/dL (female) (≥ 16 years of age)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • Albumin ≥ 2 g/dL
  • LVEF or shortening fraction normal
  • Corrected QT interval ≤ 450 msec
  • Amylase ≤ 1.5 times ULN
  • Lipase ≤ 1.5 times ULN
  • Body surface area ≥ 0.5 m²
  • Blood pressure within ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • Able to swallow sunitinib malate capsules
  • No pre-existing thyroid abnormality (hyper- or hypothyroidism) with unstable thyroid function
  • No history of allergic reaction attributed to sunitinib malate or component of sunitinib malate capsules NOTE: *For patients without bone marrow involvement

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy
  • No prior sunitinib malate
  • No prior anthracycline (any dose)
  • No prior radiotherapy to a radiation field that included the heart (including total body or craniospinal irradiation)
  • At least 3 months since prior stem cell transplantation or rescue (without total-body irradiation) and no evidence of graft-vs-host disease
  • At least 2 weeks since prior local, palliative, small-port radiotherapy (at least 6 months for radiation to ≥ 50% of pelvis)
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas)
  • At least 1 week since prior antineoplastic biologic agents
  • At least 1 week since prior and no concurrent hematopoietic growth factors
  • At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • Hypericum perforatum (St. John's wort)
    • Efavirenz
    • Tipranavir
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:

    • Azole antifungals (e.g., itraconazole or ketoconazole)
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Verapamil
    • HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)
    • Delavirdine
  • No more than 1 concurrent antihypertensive agent
  • No concurrent major surgery
  • No concurrent antithrombotic or antiplatelet agents, including any of the following:

    • Warfarin
    • Heparin
    • Low molecular weight heparin
    • Acetylsalicylic acid (aspirin)
    • Ibuprofen
    • Other nonsteroidal anti-inflammatory drugs
  • No concurrent medication for the treatment of hypertension
  • No other concurrent investigational drugs
  • No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387920

Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer     205-934-0309        
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center     317-274-2552        
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109-0286
Contact: Clinical Trials Office - C.S. Mott Children's Hospital     800-865-1125        
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi     314-454-4118        
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica     513-636-0161        
United States, Oregon
Oregon Health and Science University Cancer Institute Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Oregon Health and Science University     503-494-1080     trials@ohsu.edu    
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104-9786
Contact: Peter Adamson     215-590-6359        
United States, Texas
Baylor University Medical Center - Houston Recruiting
Houston, Texas, United States, 77030-2399
Contact: Alberto Pappo     832-822-4248        
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a     866-460-4673; 214-648-7097        
United States, Washington
Children's Hospital and Regional Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas Hawkins     206-987-3096        
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ronald M. Grant     416-813-8885        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Steven DuBois, MD UCSF Medical Center at Parnassus
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000507414, COG-ADVL0612, NCI-07-C-0220
Study First Received: October 12, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00387920  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:
Sunitinib

Additional relevant MeSH terms:
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009