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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082940 |
RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: denileukin diftitox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia |
Study Start Date: | August 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response after 8 courses proceed to follow-up. Patients achieving a partial response or stable disease after 8 courses may continue treatment at the discretion of the investigator.
Patients are followed every 3 months for 1 year and then annually until relapse.
PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse):
High-risk disease OR intermediate-risk disease
Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria:
Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
St. Joseph Hospital Regional Cancer Center - Orange | |
Orange, California, United States, 92868-3849 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
Medical Center Vincennes | |
Vincennes, Indiana, United States, 47591 | |
United States, Louisiana | |
Cancer Care Specialists | |
Houma, Louisiana, United States, 70360 | |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
Shreveport, Louisiana, United States, 71130-3932 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Health System | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1082 | |
Southeastern Medical Oncology Center | |
Goldsboro, North Carolina, United States, 27534 | |
United States, South Carolina | |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Tennessee | |
Chattanooga Oncology and Hematology Associates | |
Chattanooga, Tennessee, United States, 37404 | |
United States, Texas | |
Southwest Regional Cancer Center - Central | |
Austin, Texas, United States, 78705 |
Study Chair: | Arthur E. Frankel, MD | Wake Forest University |
Study ID Numbers: | CDR0000361734, CCCWFU-27102, CCCWFU-BG02-331, LIGAND-CCCWFU-27102 |
Study First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082940 |
Health Authority: | United States: Federal Government |
B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, B-cell, chronic Fludarabine monophosphate Leukemia Lymphatic Diseases |
Leukemia, Lymphocytic, Chronic, B-Cell Interleukin-2 Denileukin diftitox Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Sensory System Agents Analgesics, Non-Narcotic Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |