Gemcitabine in Treating Children With Refractory Solid Tumors
NCT ID: NCT00005577
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
1996-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
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.
gemcitabine hydrochloride
Interventions
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gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed malignant solid tumor Confirmation made at original diagnosis
* No bone marrow involvement
* Refractory to conventional therapy and other therapies of higher priority according to CCG Phase I/II Priority List
PATIENT CHARACTERISTICS:
* Age: 1 to 21
* Performance status: 0-2
* Life expectancy: At least 2 months
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 100,000/mm3 (transfusion independent)
* Hemoglobin at least 10 g/dL (transfusions allowed)
* Bilirubin no greater than 1.5 times normal
* AST less than 2.5 times normal
* Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope GFR at least 70 mL/min
* No seizure disorder Not pregnant or nursing
* Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* At least 2 weeks since prior cytokine therapy and recovered
* No prior bone marrow transplantation
* No more than 3 prior combination or single agent chemotherapy regimens
* At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered
1 Year
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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John S. Holcenberg, MD
Role: STUDY_CHAIR
Seattle Children's Hospital
Locations
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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 D.C., 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
Countries
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Other Identifiers
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CCG-0954
Identifier Type: -
Identifier Source: secondary_id
CDR0000064886
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02246
Identifier Type: -
Identifier Source: org_study_id
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