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 51-75 of 82

  • Regorafenib and Methotrexate in Treating Participants with Recurrent or Metastatic Non-Small Cell Lung Cancer

    This phase II trial studies how well regorafenib works together with methotrexate in treating participants with non-small cell lung cancer that has come back (recurrent) or spread to other places (metastatic). Regorafenib and methotrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving regorafenib and methotrexate may work better in treating participants with non-small cell lung cancer.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Molecular Profile of Breast Cancer in Ugandan Patients with Stage IIB-III Breast Cancer

    This phase I trial studies the molecular profile of breast cancer in Ugandan patients with stage IIB-III breast cancer. Creating a molecular profile of breast cancer my help doctors learn more about biological factors associated with breast cancer in Ugandan patients with as well as measure the benefits of locally available diagnostic studies and the possibility of providing treatment via oral medication.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • 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

  • Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients with Philadelphia Chromosome-Positive and / 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 and / or BCR-ABL positive 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

  • Fludarabine Phosphate, Busulfan, Rabbit Anti-thymocyte Globulin, Tacrolimus, and Methotrexate in Treating Participants with Blood Cancer Undergoing Stem Cell Transplant

    This pilot early phase I trial studies how well fludarabine phosphate, busulfan, rabbit anti-thymocyte globulin, tacrolimus, and methotrexate work in treating participants with blood cancer undergoing stem cell transplant. Drugs used in chemotherapy, such as fludarabine phosphate, busulfan, and 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. Rabbit anti-thymocyte globulin and tacrolimus may be an effective treatment for lowering the incidence of graft-versus-host disease caused by a transplant. Giving fludarabine phosphate, busulfan, rabbit anti-thymocyte globulin, tacrolimus, and methotrexate may work better in treating participants with blood cancer.
    Location: Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

  • Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients with B Acute Lymphoblastic Leukemia

    This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone 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, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma

    This phase II trial studies how well cisplatin, methotrexate, and gemcitabine hydrochloride given via transarterial perfusion work in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, methotrexate, and gemcitabine hydrochloride, 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. Transarterial chemoperfusion is a procedure that allows chemotherapy agents, such as cisplatin, methotrexate and gemcitabine hydrochloride, to be directly injected into the arteries that supply blood to the area where the tumor is located. Transarterial chemoperfusion with cisplatin, methotrexate, and gemcitabine hydrochloride may be an effective treatment for malignant pleural mesothelioma.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Romidepsin in Conditioning and Maintenance in Patients with T-cell Leukemia or Lymphoma Undergoing Donor Stem Cell Transplant

    This phase I / II trial studies the side effects and best dose of romidepsin when given together with busulfan and fludarabine phosphate before donor stem cell transplant (SCT) (conditioning) and alone after SCT (maintenance) in treating patients with T-cell leukemia or lymphoma. Drugs used in chemotherapy, such as romidepsin, busulfan, and fludarabine 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. Giving romidepsin together with busulfan and fludarabine phosphate may help prevent the patient's body from rejecting transplanted cells, and help kill any cancer cells that are in the body. Maintenance romidepsin may keep the cancer cells from coming back after the transplant.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

    Background: - In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given to a recipient. Sometimes the recipient s immune system destroys the donor s cells. Or donor immune cells attack the recipient s tissues, called graft-versus-host disease (GVHD). This is less likely when the recipient and donor have similar human leukocyte antigens (HLA). Researchers want to see if the drug palifermin improves the results of allogeneic SCT from HLA-matched unrelated donors. Objective: - To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and improve immune function after transplant. Eligibility: - Adults 18 years of age or older with blood or bone marrow cancer with no HLA-matched sibling, but with a possible HLA-matched donor. Design: - Participants will be screened with medical history, physical exam, and blood and urine tests. They will have scans and heart and lung exams. - Before transplant, participants will: - Have many tests and exams. These include blood tests throughout the study and bone marrow biopsy. - Get a central line catheter if they do not have one. - Have 1-3 rounds of chemotherapy. - Take more tests to make sure they can have the transplant, including medical history, physical exam, and CT scan. - Get palifermin by IV and more chemotherapy. They will get other drugs, some they will take for 6 months. - Participants will get the SCT. - After transplant, participants will: - Be hospitalized at least 3-4 weeks. - Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and biopsies. - Stay near D.C. for 3 months. - Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • JAK Inhibitor before Donor Stem Cell Transplant in Treating Patients with Primary or Secondary Myelofibrosis

    This phase II trial studies how well giving a JAK inhibitor before a donor stem cell transplant works in treating patients with myelofibrosis that developed without another condition (primary) or evolved from other bone marrow disorders (secondary). JAK inhibitors are a class of drugs that may stop the growth of abnormal cells by blocking an enzyme needed for cell growth. Giving a JAK inhibitor such as ruxolitinib before a donor stem cell transplant may help reduce symptoms of myelofibrosis such as inflammation and enlargement of the spleen, improve the patient’s general physical condition, and prevent complications from occurring after the transplant. Infusing healthy stem cells from a donor into the patient may help the patient's bone marrow work normally and make stem cells, red blood cells, white blood cells, and platelets. Giving a JAK inhibitor before a donor stem cell transplant may help improve transplant outcomes in patients with myelofibrosis.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Organ-Sparing Marrow-Targeted Irradiation before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

    This pilot clinical trial studies the side effects of organ-sparing marrow-targeted irradiation before stem cell transplant in treating patients with high-risk hematological malignancies. Total-body irradiation (TBI) is used to treat patients before an allogeneic stem cell transplant (where patients receive stem cells from another person) to eliminate leukemia cells. Newer radiation therapy can shape the radiation beam so that normal organs can be shielded, but the radiation will still reach other sites where leukemic cells exist. This type of radiation, called organ-sparing marrow-targeted irradiation (OSMI), may help more people benefit from the same dose of radiation as TBI without as many side effects.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • 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: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients with Acute Lymphoblastic Leukemia

    This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and 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. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients with Previously Untreated Acute Lymphoblastic Leukemia

    This phase I / II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. 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. 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 inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells

    Background: - Stem cell transplants from related donors (allogenic stem cell transplants) can be used to treat individuals with certain kinds of severe blood diseases or cancers, such as severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow to replace that of the recipient. Because stem cell transplants can have serious complications, researchers are interested in developing new approaches to stem cell transplants that will reduce the likelihood of these complications. - By reducing the number of white blood cells included in the blood taken during the stem cell collection process, and replacing them with a smaller amount of white blood cells collected prior to stem cell donation, the stem cell transplant may be less likely to cause severe complications for the recipient. Researchers are investigating whether altering the stem cell transplant donation procedure in this manner will improve the likelihood of a successful stem cell transplant with fewer complications. Objectives: - To evaluate a new method of stem cell transplantation that may reduce the possibly of severe side effects or transplant rejection in the recipient. Eligibility: - Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a blood disease that can be treated with allogenic stem cell transplants. - Donor: Individuals between 4 and 80 years of age who are related to the recipient and are eligible to donate blood. OR unrelated donors found through the National Marrow Donor Program. Design: - All participants will be screened with a physical examination and medical history. - DONORS: - Donors will undergo an initial apheresis procedure to donate white blood cells. - After the initial donation, donors will receive injections of filgrastim to release bone marrow cells into the blood. - After 5 days of filgrastim injections, donors will have apheresis again to donate stem cells that are present in the blood. - RECIPIENTS: - Recipients will provide an initial donation of white blood cells to be used for research purposes only. - From 7 days before the stem cell transplant, participants will be admitted to the inpatient unit of the National Institutes of Health Clinical Center and will receive regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress their immune system and prepare for the transplant. - After the initial chemotherapy, participants will receive the donated white blood cells and stem cells as a single infusion. - After the stem cell and white blood cell transplant, participants will have regular doses of cyclosporine and methotrexate to prevent rejection of the donor cells. Participants will have three doses of methotrexate within the week after the transplant, but will continue to take cyclosporine for up to 4 months after the transplant. - Participants will remain in inpatient care for up to 1 month after the transplant, and will be followed with regular visits for up to 3 years with periodic visits thereafter to evaluate the success of the transplant and any side effects.
    Location: University of Maryland / Greenebaum Cancer Center, Baltimore, Maryland

  • Combination Chemotherapy and Nelarabine in Treating Patients with T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

    This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax 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: M D Anderson Cancer Center, Houston, Texas

  • Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients with Newly Diagnosed Primary Central Nervous System Lymphoma

    This phase I / II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, 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. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma

    The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia

    RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia. PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.
    Location: See Clinical Trials.gov

  • ANG1005 in Leptomeningeal Disease From Breast Cancer

    This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.
    Location: 6 locations

  • Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy before Surgery for Patients with High-Grade Upper Urinary Tract Cancer

    This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin cisplatin, and gemcitabine 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. Adding durvalumab to chemotherapy before surgery may work better in shrinking the tumor compared to chemotherapy alone.
    Location: Location information is not yet available.

  • Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

    This phase I trial evaluates the side effects and best dose 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).
    Location: Location information is not yet available.

  • A Study to Compare Blinatumomab Alone to Blinatumomab with Nivolumab in Patients Diagnosed with First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

    This phase II trial investigates how well nivolumab when given together with blinatumomab work compared to blinatumomab alone in treating patients with CD19+ B-cell acute lymphoblastic leukemia or Down syndrome that has come back (relapsed). Blinatumomab is an antibody, which is a protein that identifies and targets foreign substances in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs that kills the cancer cell. Nivolumab is a medicine that is used to boost a patient’s immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.
    Location: Location information is not yet available.

  • Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis after Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation

    This phase II trial studies how well 3 different drug combinations prevent graft versus host disease (GVHD) after donor stem cell transplant. Calcineurin inhibitors, such as cyclosporine and tacrolimus, may stop the activity of donor cells that can cause GVHD. Chemotherapy drugs, such as cyclophosphamide and methotrexate, may also stop the donor cells that can lead to GVHD while not affecting the cancer-fighting donor cells. Immunosuppressive therapy, such as anti-thymocyte globulin (ATG), is used to decrease the body's immune response and reduces the risk of GVHD. It is not yet known which combination of drugs: 1) ATG, methotrexate, and calcineurin inhibitor 2) cyclophosphamide and calcineurin inhibitor, or 3) methotrexate and calcineurin inhibitor may work best to prevent graft versus host disease and result in best overall outcome after donor stem cell transplant.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington