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| Sponsored by: |
Ligand Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006345 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer-Related Problem/Condition Lymphoma |
Biological: denileukin diftitox Drug: dexamethasone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | An Evaluation of Corticosteroid Pretreatment in Cutaneous T-Cell Lymphoma Patients Receiving Ontak (Denileukin Difitox) |
| Study Start Date: | November 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| Veterans Affairs Medical Center - Miami | |
| Miami, Florida, United States, 33125 | |
| United States, Illinois | |
| Rush Cancer Institute | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Pennsylvania | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Arlington Cancer Center | |
| Arlington, Texas, United States, 76012 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Sheila Stewart, MD | Ligand Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000068169, LIGAND-L4389-MR-9901, NCI-V00-1614 |
| Study First Received: | October 4, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006345 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent cutaneous T-cell non-Hodgkin lymphoma drug/agent toxicity by tissue/organ recurrent mycosis fungoides/Sezary syndrome |
|
Dexamethasone Anti-Inflammatory Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Sezary Syndrome Mycosis Fungoides Hormones Lymphoma, Small Cleaved-cell, Diffuse Mycoses Cutaneous T-cell Lymphoma Lymphoma, T-Cell Analgesics Lymphoma |
Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Glucocorticoids Recurrence Lymphatic Diseases Analgesics, Non-Narcotic Interleukin-2 Denileukin diftitox Peripheral Nervous System Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous |
|
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Sensory System Agents Lymphoma, T-Cell Therapeutic Uses Analgesics Lymphoma Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type |
Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms Analgesics, Non-Narcotic Interleukin-2 Autonomic Agents Denileukin diftitox Peripheral Nervous System Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Central Nervous System Agents |
