Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma

May 29, 2013 updated by: Ligand Pharmaceuticals

An Evaluation of Corticosteroid Pretreatment in Cutaneous T-Cell Lymphoma Patients Receiving Ontak (Denileukin Difitox)

RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • Veterans Affairs Medical Center - Miami
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Hahnemann University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213-3489
        • University of Pittsburgh Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Diagnosis of persistent or recurrent cutaneous T-cell lymphoma (CTCL) and suitable for denileukin diftitox therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Albumin at least 3.0 mg/dL Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 28 days prior to and during study No known hypersensitivity to denileukin diftitox or its components (e.g., diphtheria toxin, interleukin-2, or its excipients) or to dexamethasone No concurrent serious, uncontrolled infection that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior denileukin diftitox (DAB389-interleukin-2) or DAB486-interleukin-2 No concurrent interferon Chemotherapy: No concurrent chemotherapy* No concurrent extracorporeal photochemotherapy* No concurrent systemic or combination cytotoxic chemotherapy No concurrent topical chemotherapy *For remission induction of CTCL Endocrine therapy: No other concurrent corticosteroids Radiotherapy: No concurrent electron beam radiotherapy and/or photophoresis Surgery: Not specified Other: At least 21 days since any prior anticancer therapy and recovered No other concurrent anticancer therapy for CTCL No concurrent experimental drugs or approved drugs tested in an investigational setting No concurrent topical therapy* No concurrent phototherapy* No concurrent cyclosporine No concurrent systemic retinoids *For remission induction of CTCL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ligand Pharmaceuticals

Investigators

  • Study Chair: Sheila Stewart, MD, Ligand Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

March 24, 2004

First Posted (Estimate)

March 25, 2004

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIGAND-L4389-MR-9901
  • CDR0000068169 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-V00-1614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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