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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00010192 |
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: aldesleukin Drug: rituximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial Of Rituximab And Interleukin-2 |
Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of intermediate-dose pulse interleukin-2 (IL-2).
Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose IL-2 subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose IL-2 SC on days 40-42, 54-56, 68-70, and 82-84.
Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse IL-2 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 3-30 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 or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Ohio | |
Arthur G. James Cancer Hospital - Ohio State University | |
Columbus, Ohio, United States, 43210 |
Study Chair: | Pierluigi Porcu, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000068454, OSU-00H0223, OSU-0037, NCI-130 |
Study First Received: | February 2, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00010192 |
Health Authority: | United States: Federal Government |
recurrent adult acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma |
stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma noncontiguous stage II grade 1 follicular lymphoma |
Leukemia, Lymphoid Hematologic Neoplasms Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Lymphoma, large-cell, immunoblastic Acute lymphoblastic leukemia, adult Lymphoma, large-cell Lymphoma, B-Cell Burkitt's lymphoma Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Lymphoblastic lymphoma Mantle cell lymphoma Recurrence Lymphatic Diseases Aldesleukin Interleukin-2 Burkitt Lymphoma B-cell lymphomas Lymphoma, Non-Hodgkin |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions |
Neoplasms Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |