A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias

Inclusion 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