Status:
COMPLETED
Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
AIDS-Related-Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This study will investigate the use of chemotherapy plus highly active antiretroviral therapy (HAART) in patients with Acquired Immunodeficiency Syndrome (AIDS)-related primary brain lymphoma. None of...
Detailed Description
Background: Acquired Immunodeficiency Syndrome (AIDS)-related primary central nervous system lymphoma (AR-PCNSL) is an Epstein-Barr virus (EBV)-driven lymphoproliferative process that typically result...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Positive human immunodeficiency virus (HIV) serology (previous records acceptable)
- Diagnosis of Primary Central Nervous System Lymphoma
- Confirmed histopathologic diagnosis by National Cancer Institute (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 Acquired immunodeficiency syndrome-related primary central nervous system lymphoma (AR-PCNSL) diagnosis:
- Positive brain fluro-2-deoxy-d-glucose positron emission tomography (FDG-PET) and
- Epstein Barr Virus (EBV) detected in the cerebrospinal fluid (CSF) using polymerase chain reaction (PCR)
- Age 18 years or greater
- Eastern Cooperative Oncology Group (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
- EXCLUSION CRITERIA:
- Prior therapy for central nervous system (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 long-term.
- Refusal to adhere to highly active antiretroviral therapy (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
- Pregnancy
- 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.
Exclusion
Key Trial Info
Start Date :
September 14 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00267865
Start Date
September 14 2006
End Date
September 19 2019
Last Update
June 1 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892