Overview

Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating childhood acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is comparing different combination chemotherapy regimens to see how well they work in treating children with acute lymphoblastic leukemia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
6-Mercaptopurine
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Dexamethasone
Doxorubicin
Liposomal doxorubicin
Mercaptopurine
Methotrexate
Pegaspargase
Thioguanine
Vincristine
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of previously untreated B-cell precursor acute lymphoblastic leukemia

- More than 25% L1 or L2 lymphoblasts

- No more than 25% L3 lymphoblasts

- WBC < 50,000/mm^3

- No T-cell precursor acute lymphoblastic leukemia by immunophenotyping

- Massive lymphadenopathy, massive splenomegaly, or large mediastinal mass allowed

- CNS or testicular leukemia allowed

- No patients found to have t(8;14)(q24;q32), t(8;22)(q24;q11), and t(2;8)(p11-p12;q24)
(characteristic of Burkitt's lymphoma)

PATIENT CHARACTERISTICS:

Age:

- 1 to 9

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No more than 72 hours since prior intrathecal cytarabine

Endocrine therapy:

- At least 30 days since prior systemic corticosteroids given for more than 48 hours

- Prior corticosteroids for mediastinal mass causing superior mediastinal syndrome
allowed

- Prior or concurrent inhaled corticosteroids allowed

Radiotherapy:

- Prior radiotherapy for mediastinal mass causing superior mediastinal syndrome allowed

- No concurrent spinal radiotherapy

Surgery:

- Not specified