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Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
This study has been completed.
Study NCT00021242   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes

July 11, 2001
July 23, 2008
August 2002
 
Response to therapy [ Designated as safety issue: No ]
Response to therapy
Complete list of historical versions of study NCT00021242 on ClinicalTrials.gov Archive Site
 
 
 
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

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:

  • 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.

Phase II
Interventional
Treatment, Open Label
Leukemia
Drug: docetaxel
 
Franklin JL, Seibel NL, Krailo M, Fu C, Adamson PC, Reaman G. Phase 2 study of docetaxel in the treatment of childhood refractory acute leukemias: A Children's Oncology Group report. Pediatr Blood Cancer. 2007 Aug 1; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00021242
 
CDR0000068762, COG-ADVL0023, CCG-09715
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Janet Franklin, MD, MPH Children's Hospital Los Angeles
National Cancer Institute (NCI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP