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

Children's Oncology Group

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: docetaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00021242

CDR0000068762 (Other Identifier)

ADVL0023

COG-ADVL0023 (Other Identifier)

CCG-09715 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Relapsed or Refractory ALL, AML

Experimental group

Description:

Docetaxel 60 mg/m\^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest.

Treatment:

Drug: docetaxel