Phase I Study of Carfilzomib for the Treatment of T-Cell Lymphoma
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of single agent carfilzomib in patients
with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic
T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) anaplastic lymphoma receptor
tyrosine kinase (ALK)+/ALK-, adult T-cell leukemia/lymphoma (ATLL), natural killer (NK)-cell
lymphoma (NKL), and PTCL-unspecified (PTCL-U).
II. To assess the safety and preliminary efficacy of single agent carfilzomib in patients
with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic
T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) ALK+/ALK-, adult T-cell
leukemia/lymphoma (ATLL), natural killer (NK)-cell lymphoma (NKL), and PTCL-unspecified
(PTCL-U).
III. To evaluate nuclear transcription factor kappa-B (NF-kappa B) activation in PTCL tumor
tissue and correlate that with response to carfilzomib, a novel proteosome inhibitor, which
targets NF-kappa B.
OUTLINE: This is a dose escalation study.
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and
16. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for year 1,
then every 4 months for year 2, then every 6 months for years 3 and 4, and then yearly
thereafter.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of carfilzomib, determined by incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
28 days
Yes
Julie Vose
Principal Investigator
University of Nebraska
United States: Food and Drug Administration
518-10
NCT01336920
June 2011
Name | Location |
---|---|
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
M D Anderson Cancer Center | Houston, Texas 77030 |