Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Daunorubicin Hydrochloride
  • Drug: Dexamethasone
  • Drug: Doxorubicin Hydrochloride
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Pegaspargase
  • Drug: Prednisone
  • Radiation: Radiation Therapy
  • Drug: Thioguanine
  • Drug: Vincristine Sulfate

Phase:

Phase 3

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

Ages Eligible for Study

1 Year - 30 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting