Peripheral T-cell Lymphoma Clinical Trial
Official title:
Phase I Dose-Escalation Study of Azacitidine (Vidaza) and Bortezomib (Velcade) in T-Cell Lymphoma
RATIONALE: Bortezomib and azacitidine 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 bortezomib when
given together with azacitidine in treating patients with relapsed or refractory T-cell
lymphoma.
PRIMARY OBJECTIVES I. To determine the maximum tolerated dose (MTD) of VELCADE (BORTEZOMIB)
in combination with Azacitidine in patients with relapsed/refractory CTCL/PTCL.
II. To define the specific toxicities and the dose-limiting toxicity (DLT) of VELCADE
(BORTEZOMIB) in combination with Azacitidine.
SECONDARY OBJECTIVES I. To determine the overall response rate (ORR). II. To correlate the
biological activity of Azacitidine as a demethylating agent (changes in target gene
methylation and gene expression, DNMT1 protein expression, global methylation) with clinical
endpoints and plasma pharmacokinetics of Azacitidine.
III. To characterize the biological activity of VELCADE (BORTEZOMIB) as a potential
demethylating agent.
IV. To correlate intracellular concentration of Azacitidine-triphosphate with global DNA
methylation and other biological endpoints as well as clinical response.
V. To explore the biologic role of microRNAs in determining clinical response to the VELCADE
(BORTEZOMIB) plus Azacitidine combination and achievement of the other pharmacodynamic
endpoints.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive bortezomib IV on days 4, 8, 11, and 15 and azacitidine subcutaneously (SC)
on days 1-5. Treatment repeats every 28 days for 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment patients are followed up for at least 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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