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Gemcitabine in Treating Children With Refractory Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Gemcitabine in Treating Children With Refractory Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Gemcitabine in Treating Children With Refractory Solid Tumors Clinical research trials and Gemcitabine in Treating Children With Refractory Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Gemcitabine in Treating Children With Refractory Solid Tumors. Gemcitabine in Treating Children With Refractory Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Gemcitabine in Treating Children With Refractory Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their Gemcitabine in Treating Children With Refractory Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Children With Refractory Solid Tumors  Gemcitabine in Treating Children With Refractory Solid Tumors
Gemcitabine in Treating Children With Refractory Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study over 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - 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 --Prior/Concurrent Therapy-- - Biologic: At least 2 weeks since prior cytokine therapy and recovered; No prior bone marrow transplantation - Chemotherapy: No more than 3 prior combination or single agent chemotherapy regimens; At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 1 to 21 - Performance status: 0-2 - Life expectancy: At least 2 months - Hematopoietic: 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) - Hepatic: Bilirubin no greater than 1.5 times normal; AST less than 2.5 times normal - Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope; GFR at least 70 mL/min - Other: No seizure disorder; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnHolcenberg, Study Chair, Children's Cancer Group
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Cancer Center and Beckman Research Institute, City of Hope
Los Angeles, California, 91010-3000
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Additional Information:
Study ID Numbers: CDR0000064886; CCG-0954
Study Start Date: November 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005577
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Bortezomib in Treating Children With Advanced Solid Tumors
2. Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors
3. BMS-214662 in Treating Patients With Solid Tumors
4. Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
5. Oxaliplatin in Treating Children With Advanced Solid Tumors
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Missouri Clinical Trials
Other Kansas City Clinical Trials
Gemcitabine in Treating Children With Refractory Solid Tumors
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