Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

Not Recruiting

Trial ID: NCT00075725

Age - 1 Year-30 Years Condition - Leukemia, Acute Lymphoid leukemia (ALL), Pediatric Cancer Gender - All Accepting Healthy Volunteers - No

Purpose

This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in 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 acute lymphoblastic leukemia.

Official Title

High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

Stanford Investigator(s)

Sheri Spunt

Neyssa Marina

Eligibility


Inclusion Criteria:

   - Must be eligible for and enrolled on classification study COG-AALL03B1

   - Newly diagnosed B-precursor acute lymphoblastic leukemia

      - WBC > 50,000/mm^3 for patients age 1 to 9

      - Any WBC for patients age 10 to 30 OR patients who have received prior steroid
      therapy OR patients with testicular disease

   - Whit blood cell (WBC) criteria:

      - Age 1 - 9 years: WBC >= 50,000/uL

      - Age 10 - 30 years: any WBC

      - Prior steroid therapy: any WBC

      - Testicular disease: any WBC

   - Patients shall have had no other prior cytotoxic chemotherapy with the exception of
   steroids and intrathecal cytarabine

   - Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for
   study; the dose and duration of previous steroid therapy should be carefully
   documented

   - All patients and/or their parents or legal guardians must sign a written informed
   consent

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patients with Down syndrome are ineligible to enroll onto this study

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Intervention(s):

drug: vincristine sulfate

radiation: radiation therapy

drug: cyclophosphamide

drug: cytarabine

drug: daunorubicin hydrochloride

drug: dexamethasone

drug: doxorubicin hydrochloride

drug: leucovorin calcium

drug: mercaptopurine

drug: methotrexate

drug: pegaspargase

drug: prednisone

drug: thioguanine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535

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