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


Phase 2
18 Years
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Sheila Stewart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ligand Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

LIGAND-L4389-MR-9901

NCT ID:

NCT00006345

Start Date:

November 1999

Completion Date:

March 2004

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • drug/agent toxicity by tissue/organ
  • recurrent mycosis fungoides/Sezary syndrome
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Washington University School of MedicineSaint Louis, Missouri  63110
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Arlington Cancer CenterArlington, Texas  76012
Rush Cancer InstituteChicago, Illinois  60612