Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Conditions
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Leukemia

Intervention / Treatment
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* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia M3 marrow (at least 25% blasts in bone marrow aspirate) Refractory to conventional therapy PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 OR Zubrod 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Bilirubin normal SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy No other concurrent chemotherapy for cancer Endocrine therapy: No concurrent corticosteroids except for treatment of adrenal crises with suppressed pituitary/adrenal response Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic reactions to amphotericin or transfusions Radiotherapy: Concurrent radiotherapy to localized painful lesions allowed Surgery: Not specified Other: Recovered from any prior therapy

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relapsed acute lymphoblastic and acute Myelogenous leukemia<br>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<br> <br> * Other names: NSC 613327;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the response rate to Gemcitabine | To 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. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia