Status and phase
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About
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when given together with 3-AP in treating patients with relapsed or refractory acute leukemia, chronic leukemia, or high-risk myelodysplastic syndrome.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of fludarabine. Patients are stratified according to disease (acute leukemias and myelodysplastic syndromes [MDS] vs chronic lymphocytic leukemia and prolymphocytic leukemia). Patients are assigned to 1 of 2 treatment groups.
Cohorts of 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level.
In both groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 3-34 patients will be accrued for this study.
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
High-risk myelodysplastic syndromes (MDS), including refractory anemia with excess blasts and chronic myelomonocytic leukemia
International Prognostic Scoring System (IPSS) score at least 1.5 based on the following:
Acute myeloid leukemia (AML)
Acute lymphoblastic leukemia
Acute progranulocytic leukemia
Chronic myelogenous leukemia
Chronic lymphocytic leukemia
Prolymphocytic leukemia
Received or ineligible for established curative regimens, including stem cell transplantation
Acute and chronic leukemias must be relapsed and/or refractory with progressive disease since last therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
No history of hemolytic anemia grade 2 or greater
No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Hepatic
Renal
Cardiovascular
Pulmonary
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No neuropathy grade 2 or greater
No active uncontrolled infection
No other life-threatening illness
No psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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