Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated...
Epstein-Barr Virus Associated LymphomaLymphoproliferative DisordersA two part, Phase 1b/2 study to define a recommended Phase 2 dose of VRx-3996 in combination with valganciclovir (Phase 1b) designed to evaluate the efficacy of this combination in relapsed/refractory EBV+ lymphomas.
Most Closely HLA-Matched CTLs for Relapsed Epstein Barr Virus(EBV)-Associated Diseases
Hodgkin LymphomaNon-Hodgkin Lymphoma4 morePatients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The disease has come back, may come back or has not gone away after treatment. This voluntary research study uses special immune system cells called LMP-specific cytotoxic T lymphocytes, a new experimental therapy. Some patients with these diseases show evidence of infection with the virus that causes infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of up to half of the patients with lymphomas, and in some cases of NPC and LMS, suggesting that it may play a role in causing these diseases. Those cancer cells (as well as some B cells in SCAEBV) that are infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to kill cells infected by EBV can survive in the blood and affect the tumor. This treatment with specially trained T cells has had activity against these viruses when the cells are made from patients with those diseases (or, after bone marrow transplant, from the patient's transplant donor). However, sometimes it is not possible to grow these cells; other times, it may take 2 to 3 months to make the cells, which may be too long when one has an active tumor. We are therefore asking if subjects would like to participate in this study, which tests if blood cells from a donor that is a partial match with the subject (or the transplant donor) that have been grown in the way described above can survive in the blood and affect the disease. These LMP-specific CTLs are an investigational product not approved by the Food and Drug Administration.
RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors
Adult Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-cell Lymphoma85 moreThis phase I clinical trial is studying the side effects and best dose of RO4929097 when given together with capecitabine in treating patients with refractory solid tumors. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RO4929097 together with chemotherapy may kill more tumor cells.
Bortezomib and Azacitidine in Treating Patients With Relapsed or Refractory T-Cell Lymphoma
Adult Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell Lymphoma10 moreRATIONALE: Bortezomib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with azacitidine in treating patients with relapsed or refractory T-cell lymphoma.
Vandetanib and Bevacizumab in Treating Patients With Advanced Solid Tumors or Lymphoma
Lung CancerLymphoma4 moreRATIONALE: Vandetanib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and vandetanib may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving vandetanib together with bevacizumab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and bevacizumab in treating patients with advanced solid tumors or lymphoma.
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic...
Chronic Myeloid LeukemiaAcute Myelogenous Leukemia7 moreThe primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.
Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia
T-LGL Lymphoproliferative DisordersThis study will examine the use of alemtuzumab (Campath) in patients with T cell large granular lymphocytic leukemia (T-LGL). Patients with T-LGL often have reduced white blood cells, red blood cells and platelets, and increased numbers of abnormal cells called large granular lymphocytes (LGLs). Patients may have recurrent infections, anemia, or abnormal bleeding. Campath destroys specific parts of the abnormal LGLs, which interfere with the production of normal blood cells. This study will determine whether Campath can increase blood counts and reduce the number of abnormal LGLs in patients and will examine the side effects of the drug. Patients 18 to 85 years of age with T-LGL leukemia may be eligible for this study. Participants undergo the following procedures: Before starting Campath treatment Medical history and physical examination, blood tests, electrocardiogram (ECG). Echocardiogram (heart ultrasound) and 24-hour Holter monitoring (continuous ECG recording). Bone marrow biopsy: About a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone. The procedure is done using local anesthetic. Placement of central line, if needed: An intravenous line (tube) is placed into a major vein in the chest. It can stay in the body and be used for the entire treatment period. The line is used to give chemotherapy or other medications, including antibiotics and blood transfusions, and to collect blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. Apheresis: A catheter (plastic tube) is placed in a vein in each arm. Blood is drawn from one vein and run through a cell-separating machine, where the white blood cells are collected and saved. The remaining blood is transfused back to the patients through the vein in the other arm. During Campath treatment Campath therapy: After a small test dose, patients receive10 daily infusions of Campath, each of which lasts about 2 hours. The first few infusions are given at the NIH Clinical Center so that the patient can be monitored closely. Induction therapy: Aerosolized pentamadine, valacyclovir and other medicines are given to protect against or treat various infections that commonly affect patients with suppressed immune systems. Whole blood or platelet transfusions, if needed, and injections of growth factors, if needed. Blood tests and check of vital signs (temperature, pulse, blood pressure) every day during treatment. Echocardiogram and 24-hour Holter monitor after the last dose of Campath. Follow-up evaluations after Campath treatment ends Blood tests at home or at NIH (weekly for the first 3 months, then every other week until 6 months, then annually for 5 years Echocardiogram at NIH (at 3 months only) Bone marrow biopsy at NIH (at 6 and 12 months, then as clinically indicated) One repeat apheresis collection for laboratory studies.
Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With...
LymphomaRATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy.
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and...
Accelerated Phase Chronic Myelogenous LeukemiaAcute Undifferentiated Leukemia181 moreThis clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation (TBI) together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus (HIV)-positive patients with or without cancer. Giving low doses of chemotherapy, such as fludarabine, and TBI before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.
Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
LeukemiaLymphomaRATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed or refractory lymphoproliferative disorders.