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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003245 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with recurrent or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma |
Study Start Date: | February 1998 |
OBJECTIVES:
OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being refractory (no complete response (CR) or partial response (PR) to initial therapy) vs recurrent (CR or PR to initial therapy); i.e, the following subcategories are used:
Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: This study will accrue 18 patients per stratum; if at least three patients respond, an additional 25 patients will be accrued for a total of 43 evaluable patients per stratum. The total number accrued will be 90-215 over a period of approximately 3 years.
Ages Eligible for Study: | 15 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Unless due to lymphoma:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Andre Goy, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000066124, MDA-DM-97182, NCI-T97-0103 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003245 |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia 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 Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Lymphoma, Mantle-Cell Irinotecan Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Lymphoma, large-cell, immunoblastic Lymphoma, B-Cell Lymphoma, large-cell Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Waldenstrom macroglobulinemia Lymphoma Chronic lymphocytic leukemia |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Mantle cell lymphoma Camptothecin Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Burkitt Lymphoma B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |