Clinical Trial Details
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[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00267865 : Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma
PhasePhase 2
AgesMin: 18 Years Max: 99 Years

Positive HIV serology (previous records acceptable)

- Diagnosis of Primary Central Nervous System Lymphoma

- Confirmed histopathologic diagnosis by NCI Laboratory of Pathology

- 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

- Positive brain FDG-PET and

- EBV detected in the CSF using PCR

- Age 18 years or greater

- ECOG performance less than or equal to 0-4

- Ability to understand and willing to provide informed consent

- If patient unable to understand informed consent, a previously designated durable
power of attorney for healthcare or an individual with legal authority may substitute
in this capacity

- Assignment of a durable power of attorney for healthcare if not already done


- Prior therapy for CNS lymphoma

- Steroids not an exclusion

- Evidence of lymphoma outside of the central nervous system

- Ocular involvement will not exclude

- Multidrug resistant HIV not amenable to long-term suppression based on either or both:

- Clinical history of poor adherence to multiple antiretroviral drugs deemed sufficient
to render effective HIV control unattainable;

- HIV mutational analysis (genotyping and/or phenotyping) that reveals high-level
resistance to more than 1 class of anti-HIV drugs such that a combination regimen
comprised of agents from at least two drug classes can not be devised to suppress HIV

- Refusal to adhere to HAART

- Concurrent malignancy other than Kaposi sarcoma, resectable squamous cell or basal
cell skin cancer, or T1 anal cancer amenable to surgical resection.

- Heart failure, Class IV by New York Heart Association criteria

- Chronic Liver Disease, Child-Pugh class B or C


- Refusal to practice contraception during chemotherapy.

- Any condition or set of circumstances that the Principal Investigator or Protocol
Chair interprets as creating undue risk to the patient by participating on this study
or would make the patient unlikely to comply with the study.
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