This is a phase I trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with high-dose etoposide and cyclophosphamide. This is an initial step in developing a novel myeloablative preparative regimen for autologous hematopoietic stem cell transplantation (ASCT). While this phase I trial will initially develop the regimen in patients with refractory disease, it is expected that it will find its best application in patients with less advanced disease.
All patients will receive the same doses of etoposide and cyclophosphamide. The dose of clofarabine will be escalated in successive cohorts of patients. Using a standard dose escalation design, successive cohorts of 3 patients will be treated with escalating doses of clofarabine (see Section 5.5 below). At the MTD (or highest dose-level if the MTD is not reached), the cohort will be expanded to 10 patients to better investigate correlative studies and give some preliminary idea of efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Cohort N Clofarabine (mg/m2/day) 1. 3-6 30 2. 3-6 40 3. 3-6 50 4. 3-6 60 5. 6-10 70
Indiana University Cancer Center
Indianapolis, Indiana, United States
Determine the maximum tolerated dose (MTD) of clofarabine in association with high-dose etoposide and cyclophosphamide followed by ASCT in patients with refractory lymphoma malignancies.
Time frame: 1 yr
Assessment of the toxicity of the combination of clofarabine, and high-dose etoposide and cyclophosphamide-- Describe engraftment kinetics-- Describe the response rate-- Describe relapse rate and event-free survival-- Assess clofarabine p
Time frame: 1 year
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