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Prospective Phase II Study of R-CODOX-M/IVAC, including Central Nervous System Penetration and Intensive Intrathecal Prophylaxis, in HIV-associated Burkitt's and Atypical Burkitt's Lymphoma

[Protocol 07-033]

Full Title :
PROSPECTIVE PHASE II STUDY OF HIGH DOSE, SHORT COURSE REGIMEN (R-CODOX-M/IVAC) INCLUDING CNS PENETRATION AND INTENSIVE IT PROPHYLAXIS IN HIV-ASSOCIATED BURKITT'S AND ATYPICAL LYMPHOMA (AMC #048)
Purpose :

The purpose of this study is to evaluate a treatment called R-CODOX-M/IVAC in patients with previously untreated HIV-associated or atypical Burkitt's lymphoma. This treatment -- which involves a combination of the chemotherapy drugs rituximab (R), cyclophosphamide (C), vincristine (O), doxorubicin (DOX, also known as Adriamycin), methotrexate (M), ifosfamide (I), etoposide (V, also known as VP-16), and cytarabine (AC) -- is already one of the standard treatments for patients with Burkitt's lymphoma who do not have HIV infection.

The CODOX-M/IVAC regimen, which does not include rituximab, has been successfully used in some patients with HIV infection, but it has not been studied extensively. Rituximab is a manmade protein designed to fight infection by interacting with certain cells, including the cells that make up lymphoma. Giving rituximab to HIV-negative lymphoma patients has been shown to help chemotherapy work better. The treatment has also been given to HIV-positive lymphoma patients, but it is not yet known if it improves their outcome.

In this study, some of the chemotherapy agents will be modified and given on a slightly different dosing schedule to make the treatment easier to tolerate. The treatment regimen also includes chemotherapy administered to the spinal fluid, which is always assessed for cancer cells. In this study, investigators will also examine patients' spinal fluid with a protein test to see if it is more sensitive than routine testing.

Eligibility :

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

  • Patients must have previously untreated HIV-associated Burkitt's lymphoma or atypical Burkitt's lymphoma. Patients may have had up to 7 days of prior steroid therapy.
  • Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. Ariela Noy at 212-639-7423.

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