Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	21 and under at time of initial diagnosis	NCI	COG-ADVL0023 CCG-09715, NCT00021242, ADVL0023

Objectives

1. Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel.
2. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed acute lymphoblastic or acute myeloid leukemia
  • M3 bone marrow relapse required



• Refractory to conventional chemotherapy



• No extramedullary disease at relapse

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

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

Expected Enrollment

A total of 10-20 patients will be accrued for this study within 1 year.

Outcomes

Response to therapy

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.

Franklin JL, Seibel NL, Krailo M, et al.: Phase 2 study of docetaxel in the treatment of childhood refractory acute leukemias: a Children's Oncology Group report. Pediatr Blood Cancer 50 (3): 533-6, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Janet Franklin, MD, MPH, Protocol chair		Ph: 323-669-5600

Registry Information
Official Title		A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias
Trial Start Date		2002-08-19
Registered in ClinicalTrials.gov		NCT00021242
Date Submitted to PDQ		2001-05-24
Information Last Verified		2005-11-29
NCI Grant/Contract Number		CA57746

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