A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia

- M3 marrow (at least 25% blasts in bone marrow aspirate)

- Refractory to conventional therapy

PATIENT CHARACTERISTICS:

Age:

- 21 and under at diagnosis

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- At least 2 months

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin normal

- SGOT or SGPT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine 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:

- No concurrent immunomodulating agents

Chemotherapy:

- At least 2 weeks since prior chemotherapy

- No other concurrent chemotherapy for cancer

Endocrine therapy:

- No concurrent corticosteroids except for treatment of adrenal crises with suppressed
pituitary/adrenal response

- Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic
reactions to amphotericin or transfusions

Radiotherapy:

- Concurrent radiotherapy to localized painful lesions allowed

Surgery:

- Not specified

Other:

- Recovered from any prior therapy