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Gemcitabine in Treating Children With Refractory Solid Tumors
This study has been completed.
Study NCT00005577   Information provided by National Cancer Institute (NCI)
First Received: May 2, 2000   Last Updated: July 23, 2008   History of Changes

May 2, 2000
July 23, 2008
August 1996
 
 
 
Complete list of historical versions of study NCT00005577 on ClinicalTrials.gov Archive Site
 
 
 
Gemcitabine in Treating Children With Refractory Solid Tumors
A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS

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.

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.

PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study over 18 months.

Phase I
Interventional
Treatment
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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

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

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

Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00005577
 
CDR0000064886, CCG-0954
Children's Cancer Group
National Cancer Institute (NCI)
Study Chair: John S. Holcenberg, MD Seattle Children's Hospital
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP