MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma
Adult Grade III Lymphomatoid Granulomatosis, B-cell Chronic Lymphocytic Leukemia, Cutaneous B-cell Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Adult Grade III Lymphomatoid Granulomatosis
Eligibility Criteria
Inclusion Criteria: Histologic proof of recurring or residual follicular B-cell non-Hodgkin's lymphoma (grade I or II), by Revised European American Lymphoma Classification (REAL) or World Health Organization (WHO) classifications which has relapsed or persisted after 3 or fewer conventional therapies, including chemotherapy or monoclonal antibody therapy; note: all patients with previously treated B-cell lymphomas of any histology with the exception of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) are eligible Tumor measurable by computed tomography (CT) scans (at least one pathologic node measuring 2.0 x 2.0 cm, or 2 nodes measuring > 1.5 x 1.5 cm after collection of tumor for immunologic analyses) At least one prior treatment regimen but no more than 3 prior chemotherapy regimens; patients previously treated with monoclonal antibodies or radiotherapy to a single site will be eligible; these therapies will be considered prior treatment regimens but will not be considered as prior chemotherapy; tumor vaccines will not be counted as prior therapies, as all such agents are investigational Absolute neutrophil count (ANC) >= 1000/uL Platelets (PLT) >= 75,000/uL Total bilirubin =< 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) =< 3 x upper limit or normal (ULN) Creatinine =< 1.5 x ULN Hemoglobin >= 8 g/dL Ability to provide informed consent Willingness to return to the Mayo Clinic Rochester or the University of California, Los Angeles for follow up Life expectancy >= 24 weeks Willingness to provide all biologic specimens as required by the protocol Exclusion Criteria: Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, 3, or 4 Any uncontrolled infection, hepatitis C virus (HCV)+ (unless HCV ribonucleic acid [RNA]-negative by polymerase chain reaction [PCR]) or hepatitis B surface antigen (HBsAg)+, or human immunodeficiency virus (HIV) positive patients or patients with known immune deficiency states Previous MDX-010 therapy regardless of interval since last treatment Prior treatment with fludarabine or 2-chlorodeoxyadenosine =< 12 months prior to registration Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment New York Heart Association classification III or IV or a history of angina pectoris requiring active treatment Clinical evidence of central nervous system involvement by lymphoma Any of the following: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) Diagnosis of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) Any requirement for concurrent steroid therapy, including use of inhaled steroids for asthma History of autoimmune disease requiring systemic therapy with immunosuppressive drugs, including but not limited to rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, or psoriasis Antinuclear antibody (ANA) titer or rheumatoid factor titer > 3x institutional ULN
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (ipilimumab)
PHASE I: Patients receive MDX-010 IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients from each group receive escalating doses of MDX-010 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive MDX-010 as in phase I at the MTD.