Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias

Conditions
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Leukemia

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

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 or Refractory ALL, AML<br>Docetaxel 60 mg/m^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest. | Drug: docetaxel<br>* Continuous IV infusion<br>* Other names: NSC #628503;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to 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. | At any time during protocol therapy | 

 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, childhood acute promyelocytic leukemia (M3)