Background:
The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments.
Objectives:
To see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug.
Eligibility:
People 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
CAT scan of the chest, abdomen, and pelvis
Tumor and bone marrow biopsies (sample taken)
Magnetic resonance imaging scan of the brain
Lumbar puncture (also known as spinal tap)
Positron emission tomography/computed tomography scan with a radioactive tracer
Every 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have:
Physical exam
Blood and pregnancy tests
Review of side effects and medications
During the study, participants will repeat most of the screening tests. They may also have other biopsies.
After stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.
...
Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI.
EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy.
Lymphomatoid granulomatosis (LYG), grades I-II
Chronic active EBV disease (CAEBV) of B-cells or T-cells
Subjects who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
Subjects with second malignancies requiring active systemic therapy are excluded. Subjects with second malignancies not requiring active systemic therapy or pre-malignant conditions such as monoclonal B-cell lymphocytosis (MBL) or monoclonal gammopathy of undetermined significance (MGUS) may be eligible.
Subjects with any condition or autoimmune disease that requires systemic corticosteroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted.
Single group
Nivolumab
Biological/VaccineNivolumab, 480 mg IV every 4 weeks for up to 2 years in subjects with responding disease with clinical benefit if they are tolerating treatment
overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHL
number of patients who respond to the protocol therapy (CR, PR, SD)
toxicity profile of nivolumab in patients with EBV-LPD
number and type of AEs experienced
PFS of patients with EBV-LPD treated with nivolumab
number of patients who do not experience progressive disease
overall survival of patients with EBV-LPD treated with nivolumab
number of patients that survive 5 years or more
duration of remission for patients who respond to nivolumab
number of months patients stay in remission
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