Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.

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

Details

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

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