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Sponsored by: |
Corixa Corporation |
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Information provided by: | Corixa Corporation |
ClinicalTrials.gov Identifier: | NCT00078598 |
A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe.
Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada – Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the “dosimetric dose,” patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patient’s weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the “therapeutic dose,” patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131–conjugated Tositumomab (35 mg).
Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: Rituximab or Iodine I 131 Tositumomab Therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Georgia | |
Northside Hospital | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Barry Boatman, RN 404-303-3355 barry.boatman@northside.com | |
Principal Investigator: Ronald Steis, MD | |
United States, Ohio | |
Medical Oncology/Hematology Associates | Not yet recruiting |
Dayton, Ohio, United States, 45409 | |
Contact: Cathy Hull, RN 937-223-2183 | |
Principal Investigator: Basel Yanes, MD | |
United States, Washington | |
St Mary Medical Center/Regional Cancer Center | Recruiting |
Walla Walla, Washington, United States, 99362 | |
Contact: Cathy McCauley, RN 509-522-5993 mccaca@smmc.com | |
Principal Investigator: Matthew Sacks, MD | |
Madigan Army Medical Center | Not yet recruiting |
Tacoma, Washington, United States, 98431 | |
Contact: Carol Dean, RN 253-968-3681 carol.ford@nw.amedd.army.mil | |
Principal Investigator: David E McCune, MD, MPH | |
United States, West Virginia | |
West Virginia University/Mary Babb Randolph Cancer Center | Not yet recruiting |
Morgantown, West Virginia, United States, 26506 | |
Contact: Robin Weisenborn, MT, CCRC 304-293-3709 WeisenbornR@rcbhsc.wvu.edu | |
Principal Investigator: Solveig Ericson, MD, PhD |
Study ID Numbers: | CCBX001-049 |
Study First Received: | March 1, 2004 |
Last Updated: | November 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00078598 |
Health Authority: | United States: Food and Drug Administration |
Relapsed Follicular |
Immunoproliferative Disorders Rituximab Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Iodine-131 anti-B1 antibody Antibodies, Monoclonal Lymphatic Diseases |
Antibodies 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 Antirheumatic Agents |