Spots Global Cancer Trial Database for Gemcitabine in Treating Children With Refractory Solid Tumors
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Trial Identification
Brief Title: Gemcitabine in Treating Children With Refractory Solid Tumors
Official Title: A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS
Study ID: NCT00005577
Interventions
Study Description
Brief Summary: Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description: OBJECTIVES: I. Estimate the maximum tolerated dose of gemcitabine in children and adolescents with refractory solid tumors. II. Assess the toxicity of gemcitabine in this patient population. III. Determine the pharmacokinetic profile of gemcitabine in male and female children and adolescents. IV. Assess the antitumor activity of gemcitabine within a phase I study. OUTLINE: This is a dose escalation study. Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine 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. Patients are followed at week 4 and then every 6 months until death.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Cancer Center and Beckman Research Institute, City of Hope, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Contact Details
Name: John S. Holcenberg, MD
Affiliation: Seattle Children's Hospital
Role: STUDY_CHAIR
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