Leukemia Clinical Trial
Official title:
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Adults and Children With Relapsed or Refractory Acute Leukemias
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in
different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine and
cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic
myelogenous leukemia, or myeloproliferative disorders.
OBJECTIVES:
Primary
- Determine the feasibility and tolerability of administering clofarabine and
fractionated cyclophosphamide in patients with relapsed or refractory acute leukemia,
chronic myelogenous leukemia, or high-risk myeloproliferative disorders
- Determine the maximum tolerated dose of clofarabine and fractionated cyclophosphamide
in these patients.
- Determine the toxic effects of these drugs in these patients.
Secondary
- Obtain preliminary data of biologic and pharmacodynamic effects of this regimen on
marrow and circulating leukemic blasts in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to age (adult vs
child).
Patients receive cyclophosphamide IV over 2 hours on day 0. Patients then receive
clofarabine IV over 2 hours and cyclophosphamide IV over 2 hours on days 1-3 and 8-10.
Treatment with clofarabine and cyclophosphamide repeats every 28 days for at least 2 courses
in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of clofarabine and cyclophosphamide 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. At least 10
patients are treated at the MTD.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
;
Primary Purpose: Treatment
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