Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
About this trial
This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility Criteria
Inclusion Criteria: Diagnosis of 1 of the following: Acute myeloid leukemia Myelodysplastic syndromes, including 1 of the following: Refractory anemia with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts Acute lymphoblastic leukemia Chronic myelogenous leukemia in blastic phase Relapsed or refractory disease, defined as 1 of the following: Failed to achieve a complete response (CR) to a standard induction regimen Relapsed after achieving a CR Failed last cytotoxic regimen before study entry No alternate, potentially curative option available No known CNS disease Performance status - ECOG 0-2 SGOT and SGPT normal Bilirubin normal Creatinine normal No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119) No concurrent uncontrolled illness No active or ongoing infection No psychiatric illness or social situation that would preclude study compliance No prior allogeneic stem cell transplantation No concurrent prophylactic hematopoietic colony-stimulating factors (CSF) No epoetin alfa or hematopoietic CSF during course 1 of study therapy More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea More than 7 days since prior radiotherapy Recovered from all prior therapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer agents or therapies No other concurrent antileukemic agents or therapies No other concurrent investigational agents or therapies No other concurrent cytotoxic agents
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (becatecarin)
Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 1 additional course beyond CR. Patients achieving a PR or HI receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.