Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Phase I Study of AR-42 in Relapsed Myeloma, Chronic Lymphocytic Leukemia, and Lymphoma
RATIONALE: AR-42 may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of AR-42 in treating
patients with advanced or relapsed multiple myeloma, chronic lymphocytic leukemia, or
lymphoma.
PRIMARY OBJECTIVES:
I. To estimate the safety by estimating the maximum tolerated dose (MTD) and describe the
dose limiting toxicity (DLT) of AR-42 administered orally three times weekly (Mon, Wed, and
Fri preferred) each week for 3 weeks during each 28-day period to adults with advanced or
recurrent chronic lymphocytic leukemia (CLL), lymphoma, or multiple myeloma (MM).
SECONDARY OBJECTIVES:
I. To characterize the pharmacokinetics of AR-42 in this patient population. II. To analyze
patient samples for descriptive information regarding AR-42 pharmacodynamic changes in this
patient population.
III. To obtain pilot data regarding efficacy at the MTD as measured by partial and complete
responses in each disease subgroup during protocol expansion in stage III.
OUTLINE:
Patients receive oral AR-42 three times weekly on days 1-21. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days.
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