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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00062894 |
The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: Iodine I 131 Tositumomab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma |
Enrollment: | 12 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | April 2007 |
This is a multi-center study in which 12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab followed by a therapeutic dose of tellurium-derived Iodine I 131 Tositumomab. Blood Pharmacokinetics, total body clearance, tumor and organ dosimetry, and biodistribution will be assessed following administration of the dosimetric dose.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Bay Pines VA Medical Center | |
Bay Pines, Florida, United States, 33744 | |
United States, Illinois | |
Rush Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Michigan | |
University of Michigan Medical Center | |
Ann Arbor, Michigan, United States, 48109-0936 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-7680 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | CCBX001-048 |
Study First Received: | June 17, 2003 |
Last Updated: | September 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00062894 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Iodine I 131 Tositumomab BEXXAR non-Hodgkin's lymphoma |
Anti-Infective Agents Immunoproliferative Disorders Immunologic Factors Lymphoma, Follicular Iodine-131 anti-B1 antibody Trace Elements Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Antibodies, Monoclonal |
Anti-Infective Agents, Local Lymphatic Diseases Antibodies Iodine Micronutrients Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Anti-Infective Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Lymphoma, Follicular Iodine-131 anti-B1 antibody Trace Elements |
Pharmacologic Actions Antibodies, Monoclonal Lymphatic Diseases Anti-Infective Agents, Local Neoplasms Therapeutic Uses Iodine Micronutrients Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |