Clinical Trials Using Methotrexate

Clinical trials are research studies that involve people. The clinical trials on this list are studying Methotrexate. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 26-50 of 81

  • Blinatumomab, Pembrolizumab, and Methotrexate in Treating Patients with Relapsed or Refractory CD19 Positive B Acute Lymphoblastic Leukemia

    This phase I / II trial studies how well blinatumomab and pembrolizumab work in treating patients with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in the chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving blinatumomab, pembrolizumab, and methotrexate may work better in treating patients with CD19 positive B acute lymphoblastic leukemia.
    Location: 4 locations

  • High-Dose Methotrexate in Treating Patients with Breast Cancer and Leptomeningeal Metastasis

    This phase II trial studies how well high-dose methotrexate works in treating patients with breast cancer that has spread to the thin layers of tissue that cover and protect the brain and spinal cord called leptomeninges (leptomeningeal metastasis). Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 3 locations

  • Combination Chemotherapy in Treating Adult Patients with Newly Diagnosed Acute Lymphoblastic Leukemia

    This phase II trial studies how well combination chemotherapy works in treating adult patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
    Location: 3 locations

  • Risk-Adapted Therapy in Treating Young Patients with Mature B-Cell Lymphoma or Leukemia

    Many children and young adults with mature B-cell lymphoma can be cured with current standard treatments, but these standard treatments do not stop every child’s cancer from coming back. Furthermore, many children have significant side effects from treatment, both at the time of treatment and for many years after treatment is completed (late effects). That is why there is still much to be learned about this disease and its treatment. This study is being done to help researchers learn more about the biology and genetics of this disease in children in the United States (U.S.) and at several international sites and to study the effects (good and bad) of this treatment in St. Jude participants in order to help researchers guide treatment for children and young adults with this disease in the future.
    Location: 2 locations

  • Treosulfan and Fludarabine Phosphate before Donor Stem Cell Transplant in Treating Patients with Nonmalignant Inherited Disorders

    This phase II clinical trial studies how well treosulfan and fludarabine phosphate with or without low dose radiation before donor stem cell transplantation works in treating patients with nonmalignant (noncancerous) diseases. Hematopoietic cell transplantation has been shown to be curative for many patients with nonmalignant (noncancerous) diseases such as primary immunodeficiency disorders, bone marrow failure syndromes, hemoglobinopathies, and inborn errors of metabolism (metabolic disorders). Powerful chemotherapy drugs and / or radiation are often used to condition the patient before infusion of the new healthy donor cells. The purpose of the conditioning therapy is to destroy the patient's abnormal bone marrow which doesn't work properly in order to make way for the new healthy donor cells which functions normally. Although effective in curing the patient's disease, many hematopoietic cell transplantation regimens use intensive chemotherapy and / or radiation which can be quite toxic, have significant side effects, and can potentially be life-threatening. Investigators are investigating whether a new conditioning regimen that uses less intensive drugs (treosulfan and fludarabine phosphate) with or without low dose radiation results in new blood-forming cells (engraftment) of the new donor cells without increased toxicities in patients with nonmalignant (noncancerous) diseases.
    Location: 3 locations

  • A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Participants With Relapsed / Refractory Acute Leukemias or Solid Tumors

    This is a Phase I / II, multicenter, open-label, multi-arm study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin, administered as a single agent or in combination with chemotherapy or venetoclax, in pediatric and young adult participants with acute leukemias or solid tumors. This study is divided into three parts: Part 1 will begin with dose escalation of idasanutlin as a single agent in pediatric participants with relapsed or refractory solid tumors to identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and to characterize dose-limiting toxicities (DLTs). Following MTD / MAD identification, three separate safety run-in cohorts in neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) will be conducted to identify the recommended Phase 2 dose (RP2D) of idasanutlin in each combination, with chemotherapy or venetoclax. Part 2 will evaluate the safety and early efficacy of idasanutlin in combination with chemotherapy or venetoclax in newly enrolled pediatric and young adult participants in neuroblastoma, AML,and ALL cohorts at idasanutlin RP2D. Part 3 will potentially be conducted as an additional expansion phase of the idasanutlin combination cohorts in neuroblastoma, AML, or ALL for further response and safety assessment.
    Location: 3 locations

  • Ribociclib in Combination with Everolimus and Dexamethasone in Treating Children and Young Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia

    This phase I trial studies the best dose and side effects of ribociclib when given with everolimus and dexamethasone, and to see how well they work in treating children and young adults with acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Ribociclib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib together with everolimus and dexamethasone may work as a possible treatment for relapsed or refractory acute lymphoblastic leukemia.
    Location: 4 locations

  • Venetoclax, Busulfan, Fludarabine, and Azacitidine in Treating Patients with High Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelodysplastic / Myeloproliferative Neoplasm Overlap Syndromes Undergoing Donor Stem Cell Transplantation

    This phase I trial studies the best dose and side effects of venetoclax when given together with busulfan, fludarabine, and azacitidine in treating patients with high risk acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, or myelodysplastic syndrome / myeloproliferative neoplasm undergoing donor hematopoietic stem cell transplantation. Drugs used in chemotherapy, such as venetoclax, busulfan, fludarabine, and azacitidine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 2 locations

  • Pevonedistat with Combination Chemotherapy for the Treatment of Recurrent or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin Lymphoma

    This phase I trial studies the side effects and best dose of pevonedistat and how well it works with combination chemotherapy in treating adolescents and young adults with acute lymphoblastic leukemia or lymphoblastic non-Hodgkin lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vincristine sulfate, dexamethasone, pegaspargase, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat with chemotherapy may work better in treating acute lymphoblastic leukemia or lymphoblastic non-Hodgkin lymphoma compared to chemotherapy alone.
    Location: 3 locations

  • Everolimus, Nelarabine, Cyclophosphamide, and Etoposide Phosphate in Treating Patients with Relapsed or Refractory T Cell Lymphoblastic Leukemia or Lymphoma

    This pilot phase I trial studies the side effects and best dose of everolimus and to see how well it works when given together with nelarabine, cyclophosphamide, and etoposide phosphate in treating patients with T cell lymphoblastic leukemia or lymphoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as everolimus, nelarabine, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 2 locations

  • Treatment for Advanced B-Cell Lymphoma

    To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy backbone (Immunochemotherapy).
    Location: 2 locations

  • Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients with Acute Leukemia

    This phase II trial compares four strategies for the reduction of graft versus host disease in patients with acute leukemia in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient’s immune cells and help destroy any remaining cancer cells.
    Location: 3 locations

  • Inotuzumab Ozogamicin in Treating Patients with MRD Positive CD22+ Relapsed B Cell Acute Lymphoblastic Lymphoma

    This phase II trial studies how well inotuzumab ozogamicin works in treating patients with minimal residual disease (MRD) positive CD22 positive (+) B cell acute lymphoblastic lymphoma that has come back. Minimal residual disease is when there is evidence for remaining tumor following initial treatment that is only apparent using highly sensitive techniques, but there are no other signs of leukemia in the bone marrow or blood yet. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22+ cancer cells in a targeted way and delivers ozogamicin to kill them.
    Location: Saint Jude Children's Research Hospital, Memphis, Tennessee

  • Durvalumab and Standard Chemotherapy before Surgery in Treating Patients with Variant Histology Bladder Cancer

    This phase II trial studies the side effects of durvalumab and chemotherapy before surgery in treating patients with variant histology bladder cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, cisplatin, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab in addition to standard chemotherapy may lead to better outcomes in patients with variant histology bladder cancer.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Inotuzumab Ozogamicin and Chemotherapy in Treating Patients with Leukemia or Lymphoma Undergoing Stem Cell Transplantation

    The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Vorinostat in Preventing Graft Versus Host Disease in Children, Adolescents, and Young Adults Undergoing Blood and Bone Marrow Transplant

    This phase I / II trial studies the side effects and best dose of vorinostat in preventing graft versus host disease in children, adolescents, and young adults who are undergoing unrelated donor blood and bone marrow transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, called graft-versus-host disease. During this process, chemicals (called cytokines) are released that may damage certain body tissues, including the gut, liver and skin. Vorinostat may be an effective treatment for graft-versus-host disease caused by a bone marrow transplant.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Low-Intensity Chemotherapy and Venetoclax in Treating Patients with Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

    This phase I / II trial studies the side effects and best dose of venetoclax and how well it works in combination with low-intensity chemotherapy in patients with B- or T-cell acute lymphoblastic leukemia that has not responded to treatment or that has come back. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, including vincristine, cyclophosphamide, dexamethasone, rituximab, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with low-intensity chemotherapy may work better in treating patient with B- or T-cell acute lymphoblastic leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults with Blood Cancers Undergoing Donor Stem Cell Transplant

    This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body’s normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.
    Location: 7 locations

  • Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients with Newly Diagnosed Mantle Cell Lymphoma

    This phase II trial studies how well ibrutinib and rituximab given together with venetoclax and combination chemotherapy work in treating patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy such as, venetoclax, cyclophosphamide, vincristine, doxorubicin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, rituximab, and venetoclax together with combination chemotherapy may work better in treating patients with mantle cell lymphoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Her2-BATs for the Treatment of Breast Cancer Leptomeningeal Metastases

    This phase I trial studies the best dose and side effects of Her2-BATs in treating patients with breast cancer that has spread to the meninges (the thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Her2-BATs is an anti-cancer agent created from patients own immune cells (T-cells) coated ('armed") with and experimental drug made up of bispecific antibodies called Herceptin and OKT3. The Her2-BATs antibody is able to react against human breast cancer. An antibody is a type of protein that helps protect the body from bacteria and disease. Her2-BATs works by seeking out certain cancer cells like on breast tumor cells that have a molecule called Her2 on their surface. The Her2-BATs antibody may target the Her2 receptor on the cancer cell and use the body's own immune system to destroy those cancer cells.
    Location: University of Virginia Cancer Center, Charlottesville, Virginia

  • Ruxolitinib in Combination with Standard Chemotherapy in Treating Adolescents and Young Adults with Ph-Like Acute Lymphoblastic Leukemia

    This phase I trial studies the best dose and side effects of ruxolitinib in combination with standard chemotherapy in treating adolescents and young adults with Philadelphia (Ph)-like acute lymphoblastic leukemia. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib and chemotherapy may work better in treating patients with h-like acute lymphoblastic leukemia.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • Low-Intensity Chemotherapy and Blinatumomab in treating Patients with Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia

    This phase II trial studies how well low-intensity chemotherapy and blinatumomab work in treating patients with Philadelphia chromosome negative acute lymphoblastic leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine and vincristine sulfate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving low-intensity chemotherapy and blinatumomab may work better at treating acute lymphoblastic leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Palbociclib and Combination Chemotherapy in Treating Pediatric Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

    This phase I trial studies how well palbociclib and combination chemotherapy work in treating pediatric patients with acute lymphoblastic leukemia that has come back or does not respond to treatment. Palbociclib, dasatinib, and ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, bortezomib, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and combination chemotherapy may work better in treating pediatric patients with acute lymphoblastic leukemia.
    Location: Saint Jude Children's Research Hospital, Memphis, Tennessee

  • Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients with Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed / Refractory, Acute Lymphoblastic Leukemia

    This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients with Philadelphia Chromosome-Positive and / or BCR-ABL Positive Acute Lymphoblastic Leukemia

    This phase II trial studies how well low-intensity chemotherapy and ponatinib work in treating patients with Philadelphia chromosome-positive and / or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with rituximab and blinatumomab, may induce changes in body’s immune system and may interfere with the ability of cancer cells to grow and spread. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Granulocyte colony stimulating factor helps the bone marrow make recover after treatment. Giving low-intensity chemotherapy, ponatinib, and blinatumomab may work better in treating patients with acute lymphoblastic leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas