S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: clofarabine; cytarabine
Intervention description: Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4; Induction: 1g/m2/d; IV over 2 hrs; days 1-5 Re-induction (if necessary): 1g/m2/d; IV over 2 hrs; days 1-5 Consolidation: 1g/m2/d; IV over 2 hrs; days 1-4
Intervention MeSH terms: Cytarabine; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: recurrent adult acute lymphoblastic leukemia; L1 adult acute lymphoblastic leukemia; L2 adult acute lymphoblastic leukemia; B-cell adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, 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) may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving cytarabine together with clofarabine
      works in treating patients with relapsed or refractory acute lymphoblastic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Prior morphologic diagnosis of acute lymphoblastic leukemia (ALL)

               -  No M0, mixed lineage, or L3 (Burkitt's) ALL

          -  Refractory to a standard induction regimen OR relapsed after successful prior
             induction therapy

               -  Standard induction regimen is defined as any program of treatment that includes
                  vincristine and prednisone or high-dose cytarabine/mitoxantrone

               -  Any number of inductions or remissions allowed

          -  Must have evidence of ALL in bone marrow or peripheral blood

               -  Immunophenotyping of the blood or bone marrow lymphoblasts must be performed to
                  determine lineage (B cell, T cell, or mixed B/T cell)

               -  No extramedullary only disease in the absence of bone marrow or blood involvement

               -  Co-expression of myeloid antigens (CD13 and CD33) allowed

          -  Patients with Philadelphia chromosome-positive (Ph+) ALL or bcr/abl-positive ALL who
             were previously eligible for imatinib mesylate treatment must have received imatinib
             mesylate either alone or in combination with chemotherapy for ALL and must have either
             failed treatment or been unable to tolerate treatment

          -  No CNS involvement as determined by lumbar puncture (for previous CNS history or
             clinical signs or symptoms of CNS) or by clinical exam (if no previous history or
             signs/symptoms)

          -  Must be registered on SWOG-S9910 and SWOG-9007

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-2

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT ≤ 1.5 times ULN

          -  Bilirubin ≤ 1.5 times ULN

          -  No psychiatric disorders that would interfere with study compliance

          -  No uncontrolled systemic fungal, bacterial, viral, or other infection

          -  No other severe concurrent disease

          -  No other serious or poorly controlled medical condition that would preclude study
             participation

          -  No history of serious organ dysfunction or disease involving the heart, kidney, liver,
             or other organ system that would preclude study participation

          -  HIV negative

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No pre-existing motor or sensory neuropathy ≥ grade 2

          -  No other prior malignancies, except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  In situ cervical cancer

               -  Adequately treated stage I or II cancer in complete remission

               -  Any other prior cancer for which the patient has been disease free for ≥ 5 years

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  No prior clofarabine

          -  More than 2 weeks since prior chemotherapy, major surgery, or other investigational
             agents

          -  More than 6 weeks since prior monoclonal antibodies

          -  Prior allogeneic or autologous bone marrow transplant allowed provided the following
             criteria are met:

               -  More than 90 days since transplant

               -  No acute graft-versus-host disease (GVHD) ≥ grade 2 OR moderate or severe limited
                  chronic GVHD OR extensive chronic GVHD of any severity

          -  Prior maintenance therapy with steroids, vincristine, and/or anti-metabolite agents,
             such as, but not limited to, mercaptopurine, thioguanine, or methotrexate allowed

          -  Concurrent hydroxyurea allowed