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A Phase II Study of Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-Dose Chemotherapy with Autologous Stem Cell Rescue in Newly Diagnosed Primary CNS Lymphoma

[Protocol 04-129]


Full Title :
RITUXIMAB, METHOTREXATE, PROCARBAZINE AND VINCRISTINE FOLLOWED BY HIGH-DOSE CHEMOTHERAPY WITH AUTOLOGOUS STEM-CELL RESCUE IN NEWLY-DIAGNOSED PRIMARY CNS LYMPHOMA (PCNSL)
Purpose :

Primary central nervous system lymphoma (PCNSL) can be cured in less than half of patients with standard treatment, which includes a combination of chemotherapy and radiation therapy to the brain, but this treatment may result in serious lasting side effects. For example, most patients older than age 60 -- and some under 60 -- develop memory problems, difficulty walking, or inability to control their bladder. Investigators are therefore seeking better treatments.

In this study, patients with newly diagnosed PCNSL will receive initial chemotherapy with the drugs rituximab, methotrexate, procarbazine, and vincristine, followed by very high-dose chemotherapy (using the drugs busulfan, thiotepa, and cyclophosphamide) and an autologous stem cell transplant (during which blood-forming cells are removed, stored, and later given back to the patient, as a means of re-establishing the bone marrow after chemotherapy), but no radiation therapy. Similar strategies have been used to try to improve the treatment of other brain tumors and other types of lymphoma.

Doctors expect that this treatment will decrease the risk of serious side effects, and hope that more patients will be cured. The main purpose of this phase II study is to determine the safety of this new treatment plan.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of non-Hodgkin's lymphoma involving the brain that has not yet been treated with chemotherapy or radiation therapy.
  • Patients who are immunocompromised (such as kidney transplant recipients and those who are HIV-positive) may not participate.
  • Patients must be at least 18 years old but not older than 72.

For more information and to see if you are eligible for this study, please contact Antonio Omuro at 212-639-7523.

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