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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00387920 |
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 |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 2 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender as follows:
PRIOR CONCURRENT THERAPY:
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
No concurrent antithrombotic or antiplatelet agents, including any of the following:
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 |
Study Chair: | Steven DuBois, MD | UCSF Medical Center at Parnassus |
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 |
unspecified childhood solid tumor, protocol specific |
Sunitinib |
Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |