Leukemia
Conditions
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, childhood acute promyelocytic leukemia (M3)
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia.
Detailed description
OBJECTIVES: * Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 1 year.
Interventions
DRUGdocetaxel
Continuous IV infusion
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: * Histologically confirmed acute lymphoblastic or acute myeloid leukemia * M3 bone marrow relapse required * Refractory to conventional chemotherapy * No extramedullary disease at relapse PATIENT CHARACTERISTICS: Age: * 21 and under at time of initial diagnosis Performance status: * ECOG 0-2 Life expectancy: * At least 2 months Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 1.5 times normal * Alkaline phosphatase no greater than 2.5 times normal Renal: * Creatinine no greater than 1.5 times 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: * At least 7 days since prior biologic therapy and recovered * At least 6 months since prior allogeneic stem cell transplantation * No concurrent immunomodulating agents during first 2 courses of therapy * No concurrent routine filgrastim (G-CSF) Chemotherapy: * See Disease Characteristics * At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered * No prior paclitaxel or docetaxel * No other concurrent chemotherapy during first 2 courses of therapy Endocrine therapy: * No concurrent corticosteroid therapy except dexamethasone, low-dose hydrocortisone to treat allergic reactions, or treatment for adrenal crisis Radiotherapy: * Recovered from prior radiotherapy * At least 2 weeks since prior palliative local radiotherapy * At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of the pelvis * At least 6 weeks since prior substantial bone marrow radiotherapy * No concurrent radiotherapy Surgery: * Not specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to therapy | At any time during protocol therapy | The levels of pro- and anti-apoptotic proteins will be evaluated in specimens taken before and after administration of docetaxel, at the end of therapy and at the time of relapse. The average values and variance of these levels will be used to design further investigations. The pre- and post- docetaxel levels will be compared using the difference of these two values for each patient. The change in level will be assessed using a paired t-test with an appropriate transformation for normality. |
Countries
Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland, United States
Outcome results
None listed