A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes, Refractory Acute Leukemia, Refractory or Transformed Chronic Lymphocytic Leukemia, and Chronic Myelogenous Leukemia in Blastic Phase
exatecan mesylate
Anemia+29
+ Anemia, Refractory
+ Bone Marrow Diseases
Treatment Study
Summary
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the maximum tolerated dose of DX-8951f in patients with advanced myelodysplastic syndromes, refractory acute myeloid or lymphocytic leukemia, refractory or transformed chronic lymphocytic leukemia, or chronic myelogenous leukemia in blastic phase. II. Evaluate the quantitative and qualitative toxic effects of this regimen and determine the duration and reversibility of these effects in these patients. III. Make a preliminary determination of the antileukemic activity of this regimen in these patients. IV. Evaluate the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DX-8951f until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: Approximately 20-25 evaluable patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: One of the following hematologic malignancies: Advanced myelodysplastic syndromes Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia Refractory acute myeloid leukemia (AML) First salvage with primary refractory AML or first complete response (CR) no greater than 12 months in duration or at least second salvage therapy Once maximum tolerated dose is determined, intermediate AML prognosis (first CR duration greater than 12 months but less than 24 months) eligible Refractory acute lymphocytic leukemia Refractory or transformed chronic lymphocytic leukemia Chronic myelogenous leukemia in blastic phase No CNS disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: No specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.0 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No concurrent grade 4 infection No psychiatric disorder or mental disability No other life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: At least 30 days since prior cytotoxic therapy and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy to greater than 25% of skeleton Surgery: No concurrent surgery Other: At least 3 weeks since prior investigational drugs (including analgesics or antiemetics) Recovered from toxic effects of any prior therapy
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
University of Texas - MD Anderson Cancer Center
Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps