B-Cell Lymphoma Originating in the CNS Clinical Trial
Official title:
A Phase 2a Study of the Addition of Temozolomide to a Standard Conditioning Regimen for Autologous Stem Cell Transplantation in Relapsed and Refractory Central Nervous System (CNS) Lymphoma
The primary purpose of the study will be testing the dosing of temozolomide to find the
target dose that a person can tolerate. The other part of the study will be determining how
helpful it can be to CNS lymphoma patients by adding temozolomide to the "conditioning
regimen" prior to stem cell transplantation.
This research study is designed to test the investigational use of temozolomide as part of a
conditioning regimen prior to stem cell transplantation. This drug has not yet been approved
by the U.S. Food and Drug Administration (FDA) to be used in the setting of stem cell
transplantation in lymphomas of the brain (central nervous system or CNS) but it has been
studied and used before in transplantation with reasonable results.
Currently there is no standard of care for relapsed or refractory primary central nervous
system (CNS) lymphoma. After high-dose methotrexate or radiation therapy, the best approach
to relapsed disease is undefined. Common practice is the regimen RBEAM as a conditioning
regimen in this patient population prior to transplantation. The RBEAM regimen includes R
(rituximab), B (BCNU), E (etoposide), A (Ara-C (cytarabine)) and M (melphalan). In addition,
dexamethasone is included in the regimen although not noted in the RBEAM mnemonic. However,
the melphalan used in this combination is not thought to have much CNS penetration.
Therefore, temozolomide, an alkylating agent known to penetrate the CNS and approved by the
FDA for brain tumors will be used and evaluated in this study instead of melphalan.
The aim of this study is to determine an effective and safe dose of temozolomide orally
administered to patients with relapsed primary CNS lymphoma over the 5 days preceding
autologous stem-cell transplantation. The hope is that the conditioning regimen DRBEAT [D
(dexamethasone) (R (rituximab), B (BCNU), E (etoposide), A (Ara-C (cytarabine)) and T
(temozolomide)] will significantly improve the survival of patients with relapsed CNS
lymphoma.
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