Clinical Trials Using Methotrexate

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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 1-25 of 77
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  • Gene Expression Profiling in Predicting Chemotherapy Response in Patients with Localized, Muscle-Invasive Bladder Cancer

    This randomized phase II trial studies how well looking at genes using a type of gene expression profiling called COXEN (co-expression extrapolation) works in predicting response to chemotherapy in patients with bladder cancer that has spread to the muscle of the bladder. Drugs used in chemotherapy, such as methotrexate, vinblastine sulfate, doxorubicin hydrochloride, and cisplatin, 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. Colony-stimulating factors, such as filgrastim and pegfilgrastim may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Gene expression profiling measures genetic information in various types of cells. Studying genes that affect how well patients respond to treatment may help doctors learn whether genetic information can be used in predicting treatment response and may help doctors plan the best treatment.
    Location: 578 locations

  • Combination Chemotherapy with or without Blinatumomab in Treating Patients with Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

    This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage 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. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
    Location: 422 locations

  • Chemotherapy before Surgery in Treating Patients with High Grade Upper Urinary Tract Cancer

    This phase II trial studies how well giving chemotherapy before surgery works in treating patients with aggressive upper urinary tract cancer. Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin hydrochloride, cisplatin, gemcitabine hydrochloride, 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. Removing the affected upper urinary tract by surgery is the recommended treatment for upper urinary tract cancer, but can cause loss of kidney function and prevent patients from being able to receive chemotherapy after surgery. Giving chemotherapy before surgery, when the kidneys are working at their maximum, may allow less tissue to be removed during surgery and may be more effective in treating patients with high grade upper urinary tract cancer.
    Location: 338 locations

  • Risk-Adapted Chemotherapy in Treating Younger Patients with Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

    This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). 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), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
    Location: 213 locations

  • Blinatumomab in Treating Younger Patients with Relapsed B-cell Acute Lymphoblastic Leukemia

    This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.
    Location: 158 locations

  • Azacitidine and Combination Chemotherapy in Treating Infants with Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

    This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine 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 may kill more cancer cells.
    Location: 120 locations

  • Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients with Acute Lymphoblastic Leukemia

    This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, 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. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
    Location: 179 locations

  • Imatinib Mesylate and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

    This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate 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 imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
    Location: 56 locations

  • Ruxolitinib Phosphate Before Reduced Intensity Donor Stem Cell Transplant in Treating Patients with Myelofibrosis

    This phase II trial studies how well adding ruxolitinib phosphate before a reduced intensity donor stem cell transplant works in treating patients with myelofibrosis. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ruxolitinib phosphate and chemotherapy before a donor stem cell may help stop the growth of 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.
    Location: 11 locations

  • Bortezomib, Vorinostat, and Combination Chemotherapy in Treating Infants with Newly Diagnosed Acute Lymphoblastic Leukemia

    This phase I / II trial studies the side effects and best dose of vorinostat and to see how well it works when given together with bortezomib and combination chemotherapy in treating infants (patients less than 1 year old) with newly diagnosed acute lymphoblastic leukemia. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as methotrexate, hydrocortisone, 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. Giving more than one drug (combination chemotherapy) with bortezomib and vorinostat may be a better treatment for acute lymphoblastic leukemia.
    Location: 11 locations

  • A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

    This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.
    Location: 12 locations

  • Alisertib Alone or in Combination with Chemotherapy and Radiation Therapy in Treating Younger Patients with Recurrent, Progressive, or Newly Diagnosed Central Nervous System Atypical Teratoid Rhabdoid Tumors or Extra-Central Nervous System Malignant Rhabdoid Tumors

    This phase II trial studies how well alisertib alone or in combination with chemotherapy and radiation therapy works in treating younger patients with central nervous system (CNS) atypical teratoid rhabdoid tumors that are newly diagnosed; have returned; or are growing, spreading, or getting worse or extra-CNS malignant rhabdoid tumors that have returned or are growing, spreading, or getting worse. Alisertib may stop the growth of cancer cells by blocking a protein called aurora kinase A that is needed for cell growth. Drugs used in chemotherapy 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. Radiation therapy uses x-rays to kill tumor cells. Giving alisertib alone or with chemotherapy and radiation therapy may be effective in treating patients with rhabdoid tumors.
    Location: 10 locations

  • Selinexor in Treating Younger Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

    This phase I trial studies the side effects and the best dose of selinexor in treating younger patients with acute lymphoblastic leukemia or acute myeloid leukemia that has returned or has become resistant to standard therapies. Selinexor may prevent leukemia cells from growing and may lead to the destruction of leukemia cells.
    Location: 10 locations

  • Risk Classification Schemes in Identifying Better Treatment Options for Children and Adolescents with Acute Lymphoblastic Leukemia

    This randomized phase III trial studies risk classification schemes in identifying better treatment options for children and adolescents with acute lymphoblastic leukemia. Risk factor classification may help identify how strong treatment should be for patients with acute lymphoblastic leukemia.
    Location: 5 locations

  • Panobinostat, Fludarabine Phosphate, and Cytarabine in Treating Younger Patients with Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome

    This phase I trial studies the side effects and best dose of panobinostat when given together with fludarabine phosphate and cytarabine in treating younger patients with acute myeloid leukemia or myelodysplastic syndrome that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate 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. Giving panobinostat together with fludarabine phosphate and cytarabine may kill more cancer cells.
    Location: 7 locations

  • Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

    The purpose of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
    Location: 8 locations

  • Standard Chemotherapy in Treating Young Patients with Medulloblastoma or Other Central Nervous System Primitive Neuro-ectodermal Tumors

    This randomized clinical trial studies how well standard chemotherapy works in treating young patients with medulloblastoma or other central nervous system primitive neuro-ectodermal tumors. Drugs used in standard chemotherapy 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: 5 locations

  • Ibrutinib with or without Methotrexate and Rituximab in Treating Patients with Refractory or Recurrent Primary or Secondary Central Nervous System Lymphoma

    This phase I / II trial studies the side effects and best dose of ibrutinib and to see how well it works when giving with or without methotrexate and rituximab in treating patients with primary or secondary central nervous system lymphoma that has not responded to previous treatment (refractory) or has come back (recurrent). Ibrutinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib with or without methotrexate and rituximab may work better in treating patients with primary or secondary central nervous system lymphoma.
    Location: 5 locations

  • A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

    This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).
    Location: 5 locations

  • Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults with Newly Diagnosed B Acute Lymphoblastic Leukemia

    This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy 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 inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
    Location: 4 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: 4 locations

  • Vaccine Therapy after Donor Stem Cell Transplant in Treating Patients with Advanced Myelodysplastic Syndrome or Acute Myeloid Leukemia

    This randomized phase II trial studies how well vaccine therapy after donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has spread to other places in the body (advanced). Vaccines made from a gene-modified virus and a person's tumor cells may help the body build an immune response to kill cancer cells. Giving chemotherapy before a donor peripheral blood or bone marrow transplant helps stop the growth of 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. It is not yet known whether giving vaccine therapy after a donor peripheral blood or bone marrow transplant is more effective than transplant alone in treating myelodysplastic syndrome or acute myeloid leukemia.
    Location: 4 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

  • 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: 4 locations

  • A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

    The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
    Location: 5 locations


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