Clinical Trial: Carfilzomib in Treating Patients With Relapsed or Refractory T-Cell Lymphoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase I Study of Carfilzomib for the Treatment of T-Cell Lymphoma
Brief Summary: This phase I trial studies the side effects and best dose of carfilzomib in treating patients with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Summary:
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), transformed mycosis fungoides (MF) to large cell, 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), NK-cell lymphoma (NKL), transformed mycosis fungoides (MF) to large cell, 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.
Sponsor: University of Nebraska
Current Primary Outcome: 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 [ Time Frame: 28 days ]
Original Primary Outcome:
- Maximum tolerated dose [ Time Frame: After cycle 1 (28 days) ]Defined as the highest dose tested which results in dose limiting toxicity in no more than one of six evaluable patients.
- Dose-limiting toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: When reported by patients and at physical examination (anytime during 28 days of cycle 1) ]Defined as protocol specified treatment emergent toxicities with attribution to the study drug that occur during cycle 1.
- NF-kappa B activation in PTCL tumor tissue and correlation with response to carfilzomib (correlative studies) [ Time Frame: At baseline (Average period extending from the date informed consent is obtained to the first date of study treatment) ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Nebraska
Dates:
Date Received: March 23, 2011
Date Started: June 2011
Date Completion: April 2018
Last Updated: May 23, 2017
Last Verified: May 2017