Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
Condition: Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Cyclophosphamide; Cytarabine; Daunorubicin Hydrochloride; Dexamethasone; Doxorubicin Hydrochloride; Laboratory Biomarker Analysis; Mercaptopurine; Methotrexate; Pegaspargase; Prednisone; Prophylactic Cranial Irradiation; Thioguanine; Vincristine Sulfate
Intervention description: Given IV; Given IT and IV or SC; Given IV; Given IV; Given IV; Correlative studies; Given PO; Given IT and PO; Given IV; Given IV or PO; Undergo radiation; Given PO; Given IV
Intervention MeSH terms: Cytarabine; Dexamethasone; Dexamethasone acetate; Prednisone; Cortisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Pegaspargase; Thioguanine; BB 1101; 2-Aminopurine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies the side effects of pegaspargase when given together with
      combination chemotherapy in treating patients with newly diagnosed high-risk acute
      lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of
      the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop
      the growth of cancer cells, either by killing the cells, by stopping them from dividing, or
      by stopping them from spreading. Giving more than one drug (combination chemotherapy)
      together with pegaspargase may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be eligible for and enrolled on AALL03B1 or the successor classification
             study

          -  Patients must have newly diagnosed high-risk B-precursor acute lymphoblastic leukemia
             (ALL)

          -  WBC criteria

               -  Age 1.00-9.99 years: WBC >= 50,000/uL

               -  Age 10.00 - 30.99 years: Any WBC

               -  Prior steroid therapy: Any WBC

               -  Patients with testicular leukemia: Any WBC

          -  Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids
             and intrathecal cytarabine

          -  Intrathecal chemotherapy with cytarabine is allowed prior to registration for patient
             convenience; this is usually done at the time of the diagnostic bone marrow or venous
             line placement to avoid a second lumbar puncture; the CNS status must be determined
             based on a sample obtained prior to administration of any systemic or intrathecal
             chemotherapy, except for steroid pretreatment; systemic chemotherapy must begin within
             72 hours of this intrathecal therapy

          -  Patients receiving prior steroid therapy 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:

          -  Pregnant female patients are ineligible; pregnancy tests with a negative result must
             be obtained in all post-menarchal females; males and females of reproductive potential
             may not participate unless they have agreed to use an effective contraceptive method;
             lactating females must agree that they will not breastfeed a child while on this study

          -  Patients with Down syndrome (DS) are ineligible since excessive toxicities and death
             have been noted for those enrolled on AALL0232 receiving the prednisone/Capizzi
             methotrexate (PC) arm of treatment, which is the backbone regimen for the current
             study