Lymphoma Clinical Trial
Official title:
Phase I Study of Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent B-Cell Lymphoma, Peripheral T-Cell Lymphoma or Cutaneous T-Cell Lymphoma
This phase I trial studies the side effects and best dose of giving bortezomib and romidepsin together in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), indolent B-cell lymphoma, peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). Bortezomib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) for the combination of bortezomib and
romidepsin administered weekly x 3 every (q) 4wk in patients with CLL/SLL, indolent
B-cell lymphoma, PTCL or cutaneous T-cell lymphoma (CTCL).
Secondary
- Determine safety and tolerance and describe the toxicities of the combination.
- Demonstrate adequate methods for the assessment of pharmacodynamic responses of CLL
cells to the combination with respect to effects on NF-kappa B (nuclear RelA and
processing of p52 as a marker of p100 processing), expression of the NF-kappa
B-dependent proteins XIAP and Bcl-xL, and Bim, and document pharmacodynamic responses
observed in the course of this study * Document the pharmacodynamic responses associated
with this regimen in these patients.
- Document the anticancer activity of this regimen in these patients.
OUTLINE: Patients receive bortezomib IV over 3-5 seconds and romidepsin IV over 4 hours on
days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Blood samples from patients with chronic lymphocytic leukemia are collected at baseline and
after day 1 of course 1 of study treatment for pharmacodynamic and correlative laboratory
studies.
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