A Pilot Study of Pembrolizumab in Combination With Chemotherapy in Newly Diagnosed Primary Central Nervous System Lymphoma
Dana-Farber Cancer Institute
Summary
This research study is studying if the investigational drug, Pembrolizumab, in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects. This research study involves a combination of the below drugs: * Pembrolizumab (a type of monoclonal antibody) * Methotrexate (a type of anti-metabolite) * Temozolomide (a type of alkylating agent) * Rituximab (a type of antibody)
Description
This is an open label, pilot trial of Pembrolizumab in combination with chemotherapy in participants with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL). The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab for Primary Central Nervous System Lymphoma (PCNSL) but it has been approved for other uses. The FDA has approved Rituximab for PCNSL. The FDA has not approved Temozolomide for PCNSL but it has been approved for other uses. The FDA has not approved Methotrexate for PCNSL but it has been approved for other uses. The research study procedures includ…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects with pathologically confirmed newly diagnosed primary CNS diffuse large B-cell lymphoma (DLBCL) confirmed by one of the following: * Brain biopsy or resection * Cerebrospinal fluid * Vitreous fluid * Participants must not have any evidence or history of DLBCL outside of the CNS. Participants with prior history of isolated intraocular lymphoma (primary vitreoretinal lymphoma/PVRL) who have received only local therapy are allowed. * Participants must not have received any systemic chemotherapy or whole brain radiation therapy directed to PCNSL. * Age ≥18 ye…
Interventions
- DrugPembrolizumab
Humanized immunoglobin G4 monoclonal antibody, 4 mL vials, via intravenous infusion (into the vein) per protocol.
- DrugMethotrexate
Anti-metabolite, 50 mL vials, via intravenous infusion per protocol.
- DrugTemozolomide
Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsules, taken orally per protocol.
- DrugRituximab
Anti-CD20 antibody, 10 or 50 mL single-use vials, via intravenous infusion per standard of care.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts