Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, chronic myelomonocytic leukemia, secondary acute myeloid leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, de novo myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following hematologic malignancies: Myelodysplastic syndromes (MDS) of one of the following French-American-British (FAB) classifications: Refractory anemia with excess blasts (RAEB) (WHO RAEB-1) RAEB in transformation (RAEB-t) (RAEB-2) Chronic myelomonocytic leukemia (CMML) with > 5% myeloblasts (WHO CMML-2) International Prognostic Scoring System (IPSS) score of intermediate-2 or higher in the setting of > 5% myeloblasts Acute myeloid leukemia that has evolved from MDS Must not be a candidate for bone marrow transplantation as first-line therapy or must have declined bone marrow transplantation PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Life expectancy of at least 4 months Serum potassium ≥ 4.0 milliequivalent (mEq/dL) and serum magnesium ≥ 1.8 mg/dL (supplemental electrolytes allowed) Absolute corrected QT interval (QTc) interval < 460 msec No serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent Not pregnant or nursing Fertile patients must be willing to use adequate contraception (barrier method with spermicidal jelly, intrauterine device (IUD), or oral contraceptives) Negative pregnancy test Creatinine > 2.5 mg/dL serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 1.5 times upper limit of normal Bilirubin > 2.0 mg/dL No history of malignancy within the past 3 years other than MDS except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast Arsenic trioxide is contraindicated in patients who are hypersensitive to arsenic PRIOR CONCURRENT THERAPY: No prior bone marrow transplantation Must not receive another investigational or approved therapy for MDS within 4 weeks of study enrollment, including growth factors (within 1 week of study enrollment) No prior arsenic trioxide or gemtuzumab ozogamicin No other concurrent cytotoxic drugs or investigational agents
Sites / Locations
- Cleveland Clinic Taussig Cancer Center
Arms of the Study
Arm 1
Experimental
ATO + GO
Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m^2 D8 for 1 or 2 Cycles of 12 Weeks each