Current Research: Pediatric Hematology-Oncology

AALL0433 -- Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells. It is not yet known whether low-dose vincristine is more effective than high-dose vincristine when given together with different combination chemotherapy regimens in treating acute lymphoblastic leukemia.
This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia.

Eligibility

Patients may be eligible for this trial if:

• Between 1 and 29 years of age
• Patients with an initial intermediate-risk relapse of B-precursor ALL will be eligible.
• Bone marrow relapse ≥ 36 months from initial diagnosis, or Combined bone marrow & extramedullary (CNS and/or testicular) relapse ≥ 36 monthsfrom initial diagnosis, or Isolated extramedullary (CNS and/or testicular) relapse < 18 months from diagnosis.

Exclusion criteria:

• Relapsed T-lineage ALL
• Relapsed mature B-cell (“Burkitt”) leukemia (defined as L3 morphology and/or evidenceof c-myc translocation)
• Patients with Down Syndrome (Trisomy 21) because of increased sensitivity to methotrexate
• Patients with Philadelphia-chromosome positive disease (because of the availability ofimatinib or other tyrosine kinase inhibitors)
• Patients with a history of Grade III or higher toxicity (i.e. peripheral neuropathy) attributable to vincristine within 1 month prior to study entry
• Patients with prior hematopoietic stem cell or marrow transplantation are not eligible
• CNS relapse patients with prior cranial radiotherapy of greater than 1200 cGy are not eligible

Trial Sponsor

• Children’s Oncology Group (COG); National Cancer Institute (NCI)

Project Begin Date

• Oct 2007

Tentative Project End Date

• Feb 2012

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .