Clinical trial NCT00006092 (phase 2, status: terminated)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: arsenic trioxide
SMILES: O=[As]O[As]=O
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of one of the following:

               -  Acute lymphoblastic leukemia

                    -  Philadelphia chromosome (Bcr-abl) positive

                    -  Refractory to initial therapy OR recurrent following 1 induction therapy
                       regimen with or without consolidation therapy and/or bone marrow
                       transplantation

               -  Blastic phase chronic myelogenous leukemia

                    -  Philadelphia chromosome (Bcr-abl) positive

                    -  Previously untreated OR recurrent or refractory following 1 induction
                       therapy regimen with or without consolidation therapy including imatinib
                       mesylate

          -  Must not be eligible for bone marrow transplant

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

        Life expectancy:

          -  At least 8 weeks

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Bilirubin no greater than 2.0 times upper limit of normal (ULN)

          -  AST/ALT no greater than 2 times ULN

        Renal:

          -  Creatinine no greater than 2.0 times ULN

          -  Creatinine clearance greater than 70 mL/min

        Cardiovascular:

          -  No uncontrolled angina

          -  No New York Heart Association class III or IV heart disease

          -  No second degree heart block without pacemaker

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after study

          -  HIV negative

          -  No uncontrolled infection or other serious concurrent illness

          -  No peripheral neuropathy

          -  No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR

          -  No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected

          -  Electrolyte imbalances must be corrected prior to study entry

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Disease Characteristics

        Chemotherapy:

          -  See Disease Characteristics

          -  At least 28 days since prior chemotherapy

          -  At least 24 hours since prior hydroxyurea

          -  No prior arsenic trioxide

          -  No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS
             leukemia

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  At least 28 days since prior radiotherapy

          -  No concurrent radiotherapy including for palliation

        Surgery:

          -  Not specified

        Other:

          -  At least 14 days since prior imatinib mesylate

          -  No other concurrent investigational agents

          -  No concurrent amphotericin B