|
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma Clinical research trials and Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma. Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma clinical trial. Human subjects often get the best healthcare possible for their Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma  Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
For Condition: recurrent cutaneous T-cell lymphoma,Drug Toxicity,recurrent mycosis fungoides/Sezary syndrome
Status: Completed
Sponsor(s): Ligand Pharmaceuticals ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of persistent or recurrent cutaneous T-cell lymphoma (CTCL) and suitable for denileukin diftitox therapy --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SheilaStewart, Study Chair, Ligand Pharmaceuticals
Arlington Cancer Center
Arlington, Texas, 76012
United States
Veterans Affairs Medical Center - Miami
Miami, Florida, 33125
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Rush Cancer Institute
Chicago, Illinois, 60612
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: CDR0000068169; LIGAND-L4389-MR-9901,NCI-V00-1614
Study Start Date: November 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006345
Other Drug Toxicity Studies:
1. Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
2. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
3. Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
4. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
5. 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
Related Studies:
Other Drug Toxicity Clinical Trials
Other Texas Clinical Trials
Other Arlington Clinical Trials
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
|
|
|
|
|
|
|
|
