A Phase 2 interventional study of docetaxel in Leukemia, sponsored by Children's Oncology Group. Completed at 228 sites in 7 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2014-08-08.
Sponsored by Children's Oncology Group · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed acute lymphoblastic or acute myeloid leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Docetaxel 60 mg/m\^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest.
Drug: docetaxel
Continuous IV infusion
Also known as: Taxotere®, NSC #628503
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.
Time frame: At any time during protocol therapy
Showing the first 100 of 228 sites across 7 countries.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group