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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021242 |
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.
Condition | Intervention | Phase |
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Leukemia |
Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias |
Study Start Date: | August 2002 |
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.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Study Chair: | Janet Franklin, MD, MPH | Children's Hospital Los Angeles |
Study ID Numbers: | CDR0000068762, COG-ADVL0023, CCG-09715 |
Study First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00021242 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia childhood acute promyelocytic leukemia (M3) |
Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence Acute Myeloid Leukemia, Childhood |
Docetaxel Leukemia Acute Myelocytic Leukemia Leukemia, Promyelocytic, Acute Acute Promyelocytic Leukemia Acute Lymphoblastic Leukemia |
Docetaxel Leukemia Neoplasms Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Leukemia, Myeloid Leukemia, Myeloid, Acute Pharmacologic Actions |