A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
becatecarin
+ laboratory biomarker analysis
Anemia+32
+ Anemia, Refractory
+ Anemia, Refractory, with Excess of Blasts
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of rebeccamycin analogue (XL119) in patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blastic phase. OUTLINE: This is a dose-escalation study. 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 complete response (CR) receive 1 additional course beyond CR. Patients achieving a partial response (PR) or hematologic improvement (HI) receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the maximum tolerated dose (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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location