NCT01129180

Bortezomib and Azacitidine in Treating Patients With Relapsed or Refractory T-Cell Lymphoma

Phase I Dose-Escalation Study of Azacitidine (Vidaza) and Bortezomib (Velcade) in T-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pierluigi Porcu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Nasal Type Extranodal NK/T-cell Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Hepatosplenic T-cell Lymphoma
• Peripheral T-cell Lymphoma
• Post-transplant Lymphoproliferative Disorder
• Prolymphocytic Leukemia
• Recurrent Adult T-cell Leukemia/Lymphoma
• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Small Intestine Lymphoma
• T-cell Large Granular Lymphocyte Leukemia

Interventions

Type	Name	Description
DRUG	azacitidine	Given SC
DRUG	bortezomib	Given IV
PROCEDURE	Correlative studies	Correlative studies will be collected pre-treatment, day 4 , day 15, day 29(pre-cycle 2)

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-05-01
• Completion: 2012-12-01
• First posted: 2010-05-24
• Last updated: 2013-12-03

Locations

1 site across 1 country: United States