XK469R in Treating Patients With Refractory Hematologic Cancer

Inclusion Criteria: Diagnosis of 1 of the following relapsed or refractory hematologic malignancies for which all potentially curative therapy options have been exhausted: Acute myeloid leukemia* (AML) (non-M3) Acute lymphoblastic leukemia* Myelodysplastic syndromes*, including the following: Refractory anemia with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia in transformation* (CMML-t) with ≥ 10% peripheral blood/bone marrow blasts Chronic myelogenous leukemia in blast crisis* (CML-BC) Chronic lymphocytic leukemia Rai stage III-IV Failed prior fludarabine-based therapy and ≥ 1 other therapy Fludarabine failure defined as failure to achieve partial response or complete response (CR) to at least 1 fludarabine-containing regimen; disease progression while on fludarabine; or disease progression within 6 months of response to fludarabine Not a candidate for autologous or allogeneic stem cell transplantation (SCT) Patients with previously untreated AML, MDS, or CMML-t who are considered inappropriate candidates for, or refused, standard induction chemotherapy due to older age or concurrent medical conditions are eligible No known CNS disease Performance status - ECOG 0-2 See Disease Characteristics Bilirubin < 1.5 times upper limit of normal (ULN) AST and ALT < 5 times ULN Creatinine < 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Fertile patients must use effective contraception No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No history of allergic reactions attributed to compounds of similar chemical or biologic composition to XK469R No other uncontrolled illness HIV-positive patients allowed provided CD4 counts are normal with no AIDS-defining disease No prior allogeneic SCT No concurrent prophylactic hematopoietic colony-stimulating factors More than 7 days since prior cytotoxic chemotherapy (except hydroxyurea) More than 7 days since prior radiotherapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anti-leukemia agents No other concurrent anticancer therapy