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Keep this study
Lead
Children's Oncology Group
With
National Cancer Institute (NCI)
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.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
