Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support
This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Peripheral stem cell transplant may allow the doctor to give higher doses of monoclonal antibodies and kill more cancer cells
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in
vivo purging and autologous stem cell rescue.
II. To obtain correlative laboratory data of in vivo purging with rituximab in patients with
0-35% marrow involvement.
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
(IDEC-Y2B8).
PART I: Patients receive rituximab IV on days 1, 8, 15, and 22 and cyclophosphamide IV over
1 hour on day 25. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on
day 26 and continuing until autologous peripheral blood stem cells (PBSC) are harvested.
PART II: Beginning 4-6 weeks after completion of the fourth rituximab infusion, patients
receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry
imaging on days 1, 2, 4, and 7. Patients then receive IDEC-Y2B8 IV over 10 minutes once
between days 8-15.
The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5
patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is
determined.
PART III: All patients undergo PBSC transplantation (PBSCT) beginning after residual bone
marrow radioactivity resolves. G-CSF is administered SC beginning 1 day after PBSCT and
continuing until blood counts recover.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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