Journal article
Pivotal Phase III Trial of Two Dose Levels of Denileukin Diftitox for the Treatment of Cutaneous T-Cell Lymphoma
Journal of clinical oncology, v 19(2), pp 376-388
15 Jan 2001
PMID: 11208829
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
PURPOSE: The objective of this phase III study was to determine the efficacy, safety, and pharmacokinetics of denileukin diftitox (DAB389IL-2, Ontak [Ligand Phar-maceuticals Inc, San Diego, CA]) in patients with stage Ib to IVa cutaneous T-cell lymphoma (CTCL) who have previously received other therapeutic interventions.
PATIENTS AND METHODS: Patients with biopsy-proven CTCL that expressed CD25 on ≥ 20% of lymphocytes were assigned to one of two dose levels (9 or 18 μg/kg/d) of denileukin diftitox administered 5 consecutive days every 3 weeks for up to 8 cycles. Patients were monitored for toxicity and clinical efficacy, the latter assessed by changes in disease burden and quality of life measurements. Antibody levels of antidenileukin diftitox and anti–interleukin-2 and serum concentrations of denileukin diftitox were also measured.
RESULTS: Overall, 30% of the 71 patients with CTCL treated with denileukin diftitox had an objective response (20% partial response; 10% complete response). The response rate and duration of response based on the time of the first dose of study drug for all responders (median of 6.9 months with a range of 2.7 to more than 46.1 months) were not statistically different between the two doses. Adverse events consisted of flu-like symptoms (fever/chills, nausea/vomiting, and myalgias/arthralgias), acute infusion-related events (hypotension, dyspnea, chest pain, and back pain), and a vascular leak syndrome (hypotension, hypoalbuminemia, edema). In addition, 61% of the patients experienced transient elevations of hepatic transaminase levels with 17% grade 3 or 4. Hypoalbuminemia occurred in 79%, including 15% with grade 3 or 4 changes. Tolerability at 9 and 18 μg/kg/d was similar, and there was no evidence of cumulative toxicity.
CONCLUSION: Denileukin diftitox has been shown to be a useful and important agent in the treatment of patients whose CTCL is persistent or recurrent despite other therapeutic interventions.
Metrics
Details
- Title
- Pivotal Phase III Trial of Two Dose Levels of Denileukin Diftitox for the Treatment of Cutaneous T-Cell Lymphoma
- Creators
- Elise Olsen - Duke UniversityMadeleine Duvic - Duke UniversityArthur Frankel - Duke UniversityYoun Kim - Duke UniversityAnn Martin - Duke UniversityEric Vonderheid - Drexel University, Allegheny University of the Health Sciences (1996-1998)Brian Jegasothy - Duke UniversityGary Wood - Duke UniversityMichael Gordon - Duke UniversityPeter Heald - Duke UniversityAllan Oseroff - Duke UniversityLauren Pinter-Brown - Duke UniversityGlen Bowen - Duke UniversityTimothy Kuzel - Duke UniversityDavid Fivenson - Duke UniversityFrancine Foss - Duke UniversityMichael Glode - Duke UniversityArturo Molina - Duke UniversityElizabeth Knobler - Duke UniversityStanford Stewart - Duke UniversityKevin Cooper - Duke UniversitySeth Stevens - Duke UniversityFiona Craig - Duke UniversityJames Reuben - Duke UniversityPatricia Bacha - Duke UniversityJean Nichols - Duke University
- Publication Details
- Journal of clinical oncology, v 19(2), pp 376-388
- Number of pages
- 13
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Allegheny University of the Health Sciences (1996-1998); College of Medicine
- Web of Science ID
- WOS:000166534000014
- Scopus ID
- 2-s2.0-0035863468
- Other Identifier
- 991019167610804721
UN Sustainable Development Goals (SDGs)
This publication has contributed to the advancement of the following goals:
InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Oncology