Overview
Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
Status:
Completed
Completed
Trial end date:
2007-03-01
2007-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Oncology GroupCollaborator:
National Cancer Institute (NCI)Treatments:
Cladribine
Idarubicin
Lenograstim
Sargramostim
Criteria
DISEASE CHARACTERISTICS:- One of the following diagnoses:
- Acute myeloid leukemia (AML) (FAB M0-M7)
- Secondary AML in first relapse (Secondary AML stratum closed as of 04/02/02)
- AML in primary induction failure (Refractory AML stratum closed as of 04/03/01)
- Myelodysplastic syndromes (MDS) (not related to Down syndrome) (MDS stratum
closed as of 04/03/01)
- Extramedullary disease allowed
- Relapse more than 6 months after allogeneic or autologous bone marrow transplantation
allowed
PATIENT CHARACTERISTICS:
Age:
- Under 21 at diagnosis
Performance status:
- Karnofsky 50-100% (over 10 years)
- Lansky 50-100% (10 years and under)
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 1.5 mg/dL
- ALT less than 3 times normal
Renal:
- Creatinine less than 2 times normal
Cardiovascular:
- Shortening fraction greater than 29%
- Ejection fraction greater than 55% with normal wall motion
Other:
- No uncontrolled infection
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- At least 12 weeks since prior idarubicin and recovered
- At least 2 weeks since other prior chemotherapy and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified