Clinical trial · Interventional
Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Relapsed or Refractory ALL, AML
- description
- Docetaxel 60 mg/m\^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest.
- interventionNames
- Drug: docetaxel
Primary outcomes (1)
- measure
- Response to therapy
- timeFrame
- At any time during protocol therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFranklin JL, Seibel NL, Krailo M, Fu C, Adamson PC, Reaman G; Children's Oncology Group. Phase 2 study of docetaxel in the treatment of childhood refractory acute leukemias: a Children's Oncology Group report. Pediatr Blood Cancer. 2008 Mar;50(3):533-6. doi: 10.1002/pbc.21313. PMID 17668867