Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
OHSU Knight Cancer Institute
With
OBJECTIVES: Primary * To determine the maximum tolerated dose of clofarabine in adult patients with relapsed CD20-positive B-cell non-Hodgkin lymphoma (NHL). * To estimate objective response rates of clofarabine in combination with rituximab in these patients. Secondary * To determine the 1-year progression-free survival of this regimen using the mean tolerated dose in these patients. * To determine the safety and efficacy of this regimen in these patients. * To determine if clofarabine acts as an inhibitor of DNA methylation similar to cladribine by performing scientific correlates. * To determine whether response to clofarabine alone or in combination with rituximab correlates with changes in global serum DNA methylation index. * To identify the gene activated by clofarabine therapy by using genomic DNA and RNA array technology. OUTLINE: This is a phase I, dose-escalation study of clofarabine followed by a phase II study. Patients receive oral clofarabine once daily on days 1-14 of all courses and rituximab IV on days 1, 8, 15, and 22 of course one and then on day 1 of courses 2-8. Courses repeat every 4 weeks. After 2 courses of therapy, patients who are eligible for stem cell transplantation may either undergo transplantation or continue receiving study drugs until disease progression or unacceptable toxicity for up to a total of 8 courses of treatment. Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed to identify global DNA methylation differences and correlate changes in methylation index (MI) with patient outcome after treatment with clofarabine with or without rituximab via high performance liquid chromatography (HPLC); to determine differences in gene expression via microarray analysis and micro-RNA (miRNA) expression via quantitative polymerase chain reaction (PCR) in patients with high compared to low global DNA methylation index and miRNA expression for CD5+ B-lymphocytes obtained from pediatric tonsils and from B-lymphocytes of 5 healthy controls; and to determine gene expression and miRNA profiles in patients before and after treatment with clofarabine with or without rituximab via genomic DNA arrays. After completion of study treatment, patients are followed once a year for 2 years.
Age
18–89
Sex
ALL
Healthy volunteers
Not accepted
