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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00138164 |
RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry cancer-killing substances directly to non-Hodgkin's lymphoma cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: denileukin diftitox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Multicenter Study of Ontak® (Denileukin Diftitox) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 50 |
Study Start Date: | December 2004 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive denileukin diftitox IV over 20-80 minutes on days 1-3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, and 99 (weeks 1-16) in the absence of disease progression or unacceptable toxicity. Patients achieving a partial response at week 16 may continue treatment once monthly for up to 8 additional doses or until a complete response (CR) is achieved. Patients achieving a CR (at any time) receive 2 additional monthly doses of denileukin diftitox beyond CR.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25-50 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:
Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following subtypes:
Relapsed or refractory disease
Diminished bone marrow reserve AND/OR mild to moderate cytopenia, meeting 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
Concurrent corticosteroids allowed for the following conditions:
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Principal Investigator: | Lauren C. Pinter-Brown, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000439451, UCLA-0412087-01, LIGAND-PIND-123 |
Study First Received: | August 29, 2005 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00138164 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent small lymphocytic lymphoma |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Recurrence Lymphoma, large-cell Lymphoma, B-Cell |
Lymphatic Diseases Interleukin-2 Leukemia, Lymphocytic, Chronic, B-Cell Denileukin diftitox B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
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 |