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PURPOSE: Phase II trial to study the effectiveness of dexamethasone in preventing side effects following treatment with denileukin diftitox in treating patients who have persistent or recurrent T-cell lymphoma.
OBJECTIVES: I. Evaluate the potential benefit of dexamethasone administered prior to denileukin diftitox in terms of avoidance and/or reduction of hypersensitivity type reactions, flu-like symptom complex, and vascular leak syndrome side effects (adverse events) in patients with persistent or recurrent cutaneous T-cell lymphoma. II. Assess the response rate in terms of tumor burden reduction in these patients treated with this regimen. III. Determine the rate of patient withdrawal from the study due to adverse effects.
OUTLINE: This is an open label, multicenter study. Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5. Patients also receive oral dexamethasone twice daily beginning 24 hours prior to and concomitantly with denileukin diftitox. Treatment continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 or 4 weeks.
PROJECTED ACCRUAL: Approximately 15-30 patients will be accrued for this study.
Primary Purpose: Supportive Care
Drug/Agent Toxicity by Tissue/Organ
denileukin diftitox, dexamethasone
Veterans Affairs Medical Center - Miami
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:23-0400
This is a blood and tissue study to determine the effect of the drug called denileukin diftitox on the immune system cells that may be involved in patient response to their cutaneous t-cel...
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RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry cancer-killing substances directly to non-Hodgkin's lymphoma cells. PURPOSE: This phase II trial is stud...
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The action of a drug that may affect the activity, metabolism, or toxicity of another drug.
Forms to which substances are incorporated to improve the delivery and the effectiveness of drugs. Drug carriers are used in drug-delivery systems such as the controlled-release technology to prolong in vivo drug actions, decrease drug metabolism, and reduce drug toxicity. Carriers are also used in designs to increase the effectiveness of drug delivery to the target sites of pharmacological actions. Liposomes, albumin microspheres, soluble synthetic polymers, DNA complexes, protein-drug conjugates, and carrier erythrocytes among others have been employed as biodegradable drug carriers.
An agent derived from licorice root. It is used for the treatment of digestive tract ulcers, especially in the stomach. Antidiuretic side effects are frequent, but otherwise the drug is low in toxicity.
The chilling of a tissue or organ during decreased BLOOD perfusion or in the absence of blood supply. Cold ischemia time during ORGAN TRANSPLANTATION begins when the organ is cooled with a cold perfusion solution after ORGAN PROCUREMENT surgery, and ends after the tissue reaches physiological temperature during implantation procedures. WARM ISCHEMIA TIME starts then and ends with completion of SURGICAL ANASTOMOSIS.
An irreversible inhibitor of monoamine oxidase types A and B that is used as an antidepressive agent. It has also been used as an antitubercular agent, but its use is limited by its toxicity.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...