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Investigator(s):
Robert Yarchoan, M.D. Principal Investigator Phone: 301-496-8959 ryln@nih.gov
Referral Contact(s):
Karen Aleman, R.N., B.S.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 alemank@mail.nih.gov	Kathy  Wyvill, R.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 wyvillk@mail.nih.gov

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Primary Eligibility:

• Positive HIV serology (previous records acceptable)
• Diagnosis of Primary Central Nervous System Lymphoma (Confirmed histopathologic diagnosis by NCI Laboratory of Pathology)
• Diagnostic procedures to be done at NIH on protocol 05-CC-0246
• If tissue diagnosis is not feasible for any reason, such as undue risk to the patient to acquire tissue diagnosis, the following will be accepted as confirmed AR-PCNSL diagnosis: Positive brain FDG-PET and SPECT thallium and EBV detected in the CSF using PCR
• No prior therapy for CNS lymphoma
• No prior evidence of lymphoma outside of the CNS
• No multidrug resistant HIV not amenable to long-term suppression
• No evidence of other opportunistic diseases or complications of HIV infection that would make the protocol therapy infeasible to administer

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Treatment Plan:

• Induction treatment cycles with HD-MTX and rituximab (HD-MTX-R) every 2 weeks for 6 cycles
• Two additional consolidation cycles of HD-MTX without rituximab at 4 weeks and 8 weeks following completion of the combined therapy
• MRI will be repeated at the end of cycles 2, 4, 6, and 8, and additionally as clinically indicated
• At the time of first evidence for complete tumor response by MRI criteria, FDG-PET scan and EBV DNA assessments of the blood and CSF will be repeated
• If no complete response by end of cycle 6, patients will be categorized as treatment failures and will not receive the 2 additional HD-MTX doses
• At end of treatment, restaging by MRI will be performed once every 2 months X 2; then once every 3 months X 4; then once every 6 months X 4
• After this period, clinical evaluations may continue and restaging performed if clinical suspicion of CNS pathology
• Additionally, FDG-PET scan will be repeated after cycle 8 and at 1 year

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/3/08
Updated: 1/23/07