NCT00006345

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1999

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2004

Completed
Last Updated

May 30, 2013

Status Verified

November 1, 2001

First QC Date

October 4, 2000

Last Update Submit

May 29, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganLymphoma

Keywords

recurrent cutaneous T-cell non-Hodgkin lymphomadrug/agent toxicity by tissue/organrecurrent mycosis fungoides/Sezary syndrome

Interventions

denileukin diftitoxBIOLOGICAL
dexamethasoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Veterans Affairs Medical Center - Miami

Miami, Florida, 33125, United States

Location

Rush Cancer Institute

Chicago, Illinois, 60612, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLymphomaLymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Interventions

denileukin diftitoxDexamethasone

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Sheila Stewart, MD

    Ligand Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2000

First Posted

March 25, 2004

Study Start

November 1, 1999

Study Completion

March 1, 2004

Last Updated

May 30, 2013

Record last verified: 2001-11

Locations

US(11)