Leukemia
Conditions
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia
Brief summary
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
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.
Interventions
DRUGgemcitabine hydrochloride
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland, United States
Outcome results
None listed