Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00006462|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 20, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: gemcitabine hydrochloride||Phase 2|
- Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine.
- Assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia).
Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia|
|Study Start Date :||April 2001|
|Primary Completion Date :||August 2003|
|Study Completion Date :||September 2006|
Experimental: Relapsed acute lymphoblastic and acute Myelogenous leukemia
Gemcitabine hydrochloride will be given as 10 mg/m2/min x 360 minutes weekly for three weeks. After a one-week rest period it may be repeated in patients without progressive disease or limiting toxicity.
Drug: gemcitabine hydrochloride
Other Name: NSC 613327
- Determine the response rate to GemcitabineTo determine the response rate to Gemcitabine administered as 10 mg/m2/min x 360 minutes weekly for 3 weeks in patients with relapsed acute lymphoblastic and acute myelogenous leukemia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006462
Show 225 Study Locations
|Study Chair:||Anne Angiolillo, MD||Children's Research Institute|