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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

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