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Brief Title: Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
Official Title: Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma
Study ID: NCT04609046
Brief Summary: This phase I trial is to find out the best dose, possible benefits and/or side effects of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).
Detailed Description: PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with high dose-methotrexate (HD-MTX) and rituximab, with or without nivolumab, as induction treatment of primary CNS lymphoma. II. Determine the proportion of patients who are able to stay on maintenance therapy with lenalidomide and/or nivolumab for 6 months after induction treatment of primary CNS lymphoma. SECONDARY OBJECTIVES: I. To evaluate the overall response rate (ORR) of the combination of methotrexate, rituximab, lenalidomide, nivolumab. II. To evaluate the effect of the treatment regimen and lenalidomide / nivolumab maintenance on progression free survival (PFS). III. To evaluate the effect of the treatment regimen and lenalidomide / nivolumab maintenance on overall survival (OS). EXPLORATORY OBJECTIVES: I. To analyze tumor tissue and cerebrospinal fluid (CSF) for gene expression profiles, and to correlate these profiles with treatment outcomes. II. To determine whether CSF proteome and metabolome are predictors of outcomes (prognostic marker). III. To assess response to therapy and minimal residual disease via MRI-based metrics and minimal residual disease of blood and CSF. IV. To evaluate the relationship between neurocognitive deficits and tumor and brain volumetrics, as assessed by magnetic resonance imaging (MRI) and tumor metabolism. OUTLINE: This is a dose-escalation study of lenalidomide. INDUCTION: Patients receive rituximab intravenously (IV) on day 1, methotrexate IV over 2 hours or orally (PO) on day 2, lenalidomide PO daily on days 5-14, and nivolumab IV over 30 minutes on day 14. (In dose level IV that includes nivolumab, the doses of rituximab for cycles 2-6 may be given on the same day as nivolumab for the previous cycle). Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response, or stable disease proceed to maintenance therapy. MAINTENANCE: Within 6 weeks after the last dose of lenalidomide in induction therapy, patients receive lenalidomide PO daily on days 1-21, and nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) throughout the trial, computed tomography (CT) and positron emission tomography (PET)/CT during screening, and lumbar puncture at the end of the 6th cycle of induction, and after 6 months of maintenance. Patients may also undergo bone marrow aspirate and biopsy, testicular ultrasound and/or echocardiogram (ECHO) during screening. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for up to 3 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cedars Sinai Medical Center, Los Angeles, California, United States
UCSF Medical Center-Parnassus, San Francisco, California, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall, Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States
Broadlawns Medical Center, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Trinity Regional Medical Center, Fort Dodge, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine, United States
Maine Medical Partners - South Portland, South Portland, Maine, United States
Hickman Cancer Center, Adrian, Michigan, United States
Toledo Clinic Cancer Centers-Monroe, Monroe, Michigan, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Overlook Hospital, Summit, New Jersey, United States
Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States
North Shore University Hospital, Manhasset, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
NYP/Weill Cornell Medical Center, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Rhode Island Hospital, Providence, Rhode Island, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States
Marshfield Medical Center - Weston, Weston, Wisconsin, United States
Name: Alvaro J Alencar
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR