IRB Number:

07-001458

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this study is to decide if the addition of rituximab to a standard chemotherapy regimen improves the likelihood of the tumor responding to treatment, and to determine how well the tumor can be controlled without the use of radiation therapy.
Although rituximab is widely used and effective in the treatment of lymphoma, it is not currently known if it will work for lymphoma occurring in the brain (primary central nervous system lymphoma). When used for other lymphomas, rituximab has improved the results of chemotherapy with very little or no additional side effects.
Both chemotherapy alone and chemotherapy combined with radiation have been effective in primary central nervous system lymphoma. It is not known if the radiation is necessary, but it is known that the risk of severe side effects affecting intellect and personality (dementia) is high after combined radiation and chemotherapy. For this reason, radiation will not be used as part of this protocol. The choice of using radiation later if the disease gets worse or comes back remains, and the patient would then discuss that with their doctor.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with primary central nervous system lymphoma
-No prior chemotherapy or radiation therapy received for primary CNS lymphoma.

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Before starting the study
If agreeing to be in the study, patients will be asked to participate in the following exams, tests or procedures. These are part of regular cancer care and may be done even if the patient does not take part in the study. If the patient has had some of them recently, they may not need to be done again. This will be up to their doctor.

- Physical exam
- MRI or CT of the brain
- Blood tests, including a test for HIV
- Eye exam
- CT scans of the chest, abdomen, and pelvis
- Lumbar puncture (spinal tap)
- Pregnancy test if patient is a women able to become pregnant

During the study
If the exams, tests and procedures show that the patient can be in the study, and they choose to take part, then they will need the following tests and procedures. They are part of regular cancer care.

- After starting treatment, MRI or CT of the brain at weeks 5, 10 and 14 and 3 weeks post last treatment.
- Regular blood tests and physical exams
- Lumbar puncture (spinal tap) for treatment administration in weeks 2, 4, 6, 8, and 10, but only if the lumbar puncture done at the time of initial evaluation showed
spinal fluid involvement by tumor. An alternative way to give treatment into the spinal fluid is by means of an Ommaya Reservoir. The physician will talk to the patient
about whether this is a good choice for the patient.
- Eye exam

When patient is done taking chemotherapy
Twenty-two weeks after starting treatment, an assessment will be done including physical exam, blood tests, and an MRI or CT of the brain. This assessment will be done again
every three months for the first two years following registration and every 6 months for the third, fourth, and fifth years. This is a standard follow up schedule; the patient's doctor may do these tests more often, or do additional tests, if necessary. On this study, information on their condition will continue to be collected from their doctor until five years from the date of registration.

How long will the Study run?

Patients will be in the study to take chemotherapy for 14 weeks. After they are done taking chemotherapy, the doctor will ask the patient to visit the office for follow-up
exams for at least five years.

Sponsor(s): Eastern Cooperative Oncology Group (ECOG)

Study Activation/Registration Date: 11/15/2007

IRB Review and Approval Date: 07/20/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 43 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Patrick Bruce Johnston, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/08/2008