Lymphoma Clinical Trial
Official title:
A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing
substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
monoclonal antibody therapy in treating patients who have newly diagnosed follicular
non-Hodgkin's lymphoma.
OBJECTIVES: I. Determine the 2 year failure free survival rate of patients with newly
diagnosed follicular lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) followed by iodine I 131 monoclonal antibody anti-B1. II. Determine the
complete and partial response rates of these patients after this therapy. III. Evaluate the
toxicity of this regimen in these patients. IV. Determine the rate of disappearance of cells
with clonal t(14;18)/bcl2 rearrangements from the peripheral blood and bone marrow after
this therapy in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV, and
vincristine IV on day 1 and oral prednisone on days 1-5. Treatment is repeated every 21 days
for up to 6 courses. Within 4-8 weeks after the last course of chemotherapy, patients who
achieve at least a partial response and have less than 25% bone marrow involvement begin
immunotherapy. Patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over
1 hour, then iodine I 131 MOAB anti-B1 IV over 20 minutes on day 1. This regimen is repeated
on day 8. Patients are followed every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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