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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00021242
First received: July 11, 2001
Last updated: August 7, 2014
Last verified: August 2014

July 11, 2001
August 7, 2014
August 2002
March 2006   (final data collection date for primary outcome measure)
Response to therapy [ Time Frame: At any time during protocol therapy ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00021242 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
Drug: docetaxel
Continuous IV infusion
Other Names:
  • Taxotere®
  • NSC #628503
Experimental: Relapsed or Refractory ALL, AML
Docetaxel 60 mg/m^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest.
Intervention: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2006
March 2006   (final data collection date for primary outcome measure)

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
ADVL0023, COG-ADVL0023, CCG-09715, CDR0000068762
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Janet Franklin, MD, MPH Children's Hospital Los Angeles
Children's Oncology Group
August 2014

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