Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia
Leukemia

About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, lymphoid leukemia, myeloid and monocytic leukemia
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
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Experimental
Arsenic Trioxide Treatment
Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.