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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00315731 |
Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Whole body gamma camera images will be obtained on six days following the dosimetric dose. Organ and tumor dosimetry data will be generated from gamma camera counts of specific organs and tumor. All scans will be examined by an independent review panel to evaluate biodistribution of the radionuclide.
Using the dosimetric data from three of the six imaging time points and the patient's weight, a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). Patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient specific dose of tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. Patients will be followed closely obtaining safety information during the post-treatment period, and for response and safety at 3,6,and 12 months during the first year, annually thereafter up to five years, and annually for additional safety and outcomes information up to 10 years.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma Follicular Lymphoma Diffuse Large Cell Lymphoma |
Drug: Iodine I 131 Tositumomab Therapeutic Regimen |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Historical Control, Single Group Assignment, Bio-equivalence Study |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | February 2016 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Follicular, small-cleaved; Follicular, mixed small-cleaved and large-cell; Follicular large-cell; or Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
Exclusion criteria:
United States, Florida | |
GSK Clincial Trials Call Center | Active, not recruiting |
Bay Pines, Florida, United States, 33708 | |
United States, Illinois | |
GSK Clinical Trials Call Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Stephanie Gregory 877-379-3718 | |
United States, Michigan | |
GSK Clinical Trials Call Center | Active, not recruiting |
Ann Arbor, Michigan, United States, 48109 | |
United States, Nebraska | |
GSK Clinical Trials Call Center | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Contact: Julie Vose 877-379-3718 | |
United States, North Carolina | |
GSK Clinical Trials Call Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Joe Gockerman 877-379-3718 | |
United States, Pennsylvania | |
GSK Clinical Trials Call Center | Active, not recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | 393229/027, CCBX001-048 |
Study First Received: | April 17, 2006 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00315731 |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkin's lymphoma pharmacokinetics bioequivalence Iodine I 131 Tositumomab |
tellurium fission Bexxar Iodine I 131 Tositumomab Therapeutic Regimen |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Iodine-131 anti-B1 antibody Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, large-cell Lymphatic Diseases |
Antibodies B-cell lymphomas Iodine Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma Immunoglobulins |
Anti-Infective Agents Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Trace Elements Pharmacologic Actions Anti-Infective Agents, Local Neoplasms Therapeutic Uses Micronutrients |