Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma Patients Who Have Previously Received Rituximab
This is a single-arm, open-label, multicenter study of Iodine I-131 Anti B1 Antibody
(Tositumomab and Iodine I 131 Tositumomab) for treatment of non-Hodgkin's lymphoma (NHL) who
were previously treated with rituximab antibody. Patients must have been treated with at
least 4 doses of rituximab and have progressed during or following rituximab therapy.
Patients will undergo two dosing phases of study. In the first phase, termed the "dosimetric
dose", patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70
minutes immediately followed by a 30-minute infusion of Anti-B1 Antibody (35 mg) which has
been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained
on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric
data from three imaging timepoints, a patient-specific dose of Iodine-131 will be calculated
to deliver the desired total body dose of radiotherapy. In the second phase, termed the
"therapeutic dose", patients will receive a 70-minute infusion of unlabeled Anti-B1 Antibody
(450 mg) immediately followed by a 30-minute infusion of 35 mg Anti-B1 Antibody labeled with
a patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy to patients
with no hematologic risk factors. Patients who have platelet counts of 100,001-149,999
cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of
their lean body mass. Patients will be treated with either saturated solution potassium
iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours
prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and
continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e.,
therapeutic dose).
The endpoints of the study are to determine the response rate, complete response rate,
duration of response, and time to progression or death, based on both a Masked Independent
Randomized Radiographic and Oncologic Review (MIRROR) panel and the Investigators, and the
Investigators' assessment of safety and survival of survival of Iodine-131 Anti-B1 Antibody
therapy in NHL patients who have previously been treated with rituximab.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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