Trial Search Results

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

RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium (LCV), 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.

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.

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
  • Drug: thioguanine
  • Drug: vincristine sulfate
  • Radiation: radiation therapy

Phase:

Phase 3

Eligibility


DISEASE CHARACTERISTICS:

   - 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

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

PATIENT CHARACTERISTICS:

Age

   - 1 to under 31

Performance status

   - Not specified

Life expectancy

   - Not specified

Hematopoietic

   - See Disease Characteristics

Hepatic

   - Not specified

Renal

   - Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

   - Not specified

Chemotherapy

   - No more than 72 hours since prior intrathecal cytarabine

   - No other prior cytotoxic chemotherapy

Endocrine therapy

   - Prior steroids allowed

Radiotherapy

   - Not specified

Surgery

   - Not specified

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