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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

denileukin diftitox

dexamethasone

About this trial

This is an interventional supportive care trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring recurrent cutaneous T-cell non-Hodgkin lymphoma, drug/agent toxicity by tissue/organ, recurrent mycosis fungoides/Sezary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006345

First Posted

October 4, 2000

Last Updated

May 29, 2013

Sponsor

Ligand Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00006345

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2001

Overall Recruitment Status

Completed

Study Start Date

November 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ligand Pharmaceuticals

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug/Agent Toxicity by Tissue/Organ, Lymphoma

Keywords

recurrent cutaneous T-cell non-Hodgkin lymphoma, drug/agent toxicity by tissue/organ, recurrent mycosis fungoides/Sezary syndrome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

denileukin diftitox

Intervention Type

Drug

Intervention Name(s)

dexamethasone

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheila Stewart, MD

Organizational Affiliation

Ligand Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

Veterans Affairs Medical Center - Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Rush Cancer Institute

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Tulane University School of Medicine

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Comprehensive Cancer Center at Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157-1082

Country

United States

Facility Name

Hahnemann University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102-1192

Country

United States

Facility Name

University of Pittsburgh Cancer Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213-3489

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6838

Country

United States

Facility Name

Arlington Cancer Center

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

University of Texas - MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Drug/Agent Toxicity by Tissue/Organ, Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial