A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma
NCT ID: NCT00078598
Last Updated: 2005-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
506 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Rituximab or Iodine I 131 Tositumomab Therapy
Eligibility Criteria
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Inclusion Criteria
* Recurrent lymphoma after one or two qualifying therapy regimen(s).
* A performance status of at least 70% on the Karnofsky Scale.
* An absolute neutrophil count \> 1500 cells/mm3 and a platelet count \> 100,000 cells/mm3.
* Adequate renal function and adequate hepatic function.
* Bi-dimensionally measurable disease with at least one lesion measuring \> or equal to 2.0 x 2.0 cm (i.e., \> 4.0 cm2) by CT scan.
* HAMA negative.
* At least 18 years of age.
* Give written informed consent by signing an IRB/ethics committee approved informed consent form prior to study entry.
Exclusion Criteria
* More than 1 course of rituximab
* Disease better treated with limited field therapy
* Involvement of \>25% of the intratrabecular marrow
* Active infection
* Significant cardiac disease
* Prior ChemoRx, biological therapy, radiation Rx, or high dose systemic steroid therapy within 8 weeks
* Prior radioimmunotherapy
* History of another malignancy
* HBsAg positivity
* CNS involvement with lymphoma
* Pregnant or nursing
* Ascites by physical exam
* Previous use of non-human monoclonal antibody therapy, known hypersensitive to murine proteins
* Hydronephrosis
* Radiotherapy to \>25% of the blood forming marrow
* Prior stem cell transplant
* Failed stem cell harvest
18 Years
ALL
No
Sponsors
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Corixa Corporation
INDUSTRY
Locations
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Northside Hospital
Atlanta, Georgia, United States
Medical Oncology/Hematology Associates
Dayton, Ohio, United States
Madigan Army Medical Center
Tacoma, Washington, United States
St Mary Medical Center/Regional Cancer Center
Walla Walla, Washington, United States
West Virginia University/Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Countries
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Facility Contacts
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Barry Boatman, RN
Role: primary
Cathy Hull, RN
Role: primary
Carol Dean, RN
Role: primary
Cathy McCauley, RN
Role: primary
Robin Weisenborn, MT, CCRC
Role: primary
Other Identifiers
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CCBX001-049
Identifier Type: -
Identifier Source: org_study_id