Clinical Trials Using Aldesleukin

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Aldesleukin. 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 57
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  • Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma

    Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma
    Location: 5 locations

  • A Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human Interleukin-2 (rhIL-2) Following Autologous Stem Cell Transplant for Multiple Myeloma (MM)

    This study will find the highest acceptable treatment dose and timing of infusion of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with multiple myeloma. The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is administered after treatment to help the NK cells expand in the body. The safety of this treatment will be studied and researchers want to learn if NK cells will help in treating multiple myeloma.
    Location: 3 locations

  • Low-Dose Aldesleukin and Extra-Corporeal Photopheresis in Treating Patients with Steroid-Refractory Chronic Graft-versus-Host Disease

    This phase II trial studies how well low-dose aldesleukin and extra-corporeal photopheresis (ECP) works in treating patients with chronic graft-versus-host disease (GVHD) that has not responded to steroids. Chronic GVHD is a medical condition that may occur after receiving a bone marrow, stem cell, or cord blood transplant from a donor. The donor's immune system may recognize the host's body as foreign and attempt to reject it. ECP is a procedure in which blood is removed from the body and treated with ultraviolet light and drugs that become active when exposed to light. The blood is then returned to the body. Giving aldesleukin with ECP may help control chronic GVHD by stopping the donor's immune system from rejecting the body.
    Location: 2 locations

  • High-Dose Aldesleukin and Ipilimumab in Treating Patients with Stage III-IV Melanoma That Cannot Be Removed By Surgery

    This phase II trial studies how well high-dose aldesleukin and ipilimumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Biological therapies, such as aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as ipilimumab, interfere with the ability of tumor cells to grow and spread. Giving high-dose aldesleukin together with ipilimumab may work better in treating patients with melanoma.
    Location: 4 locations

  • Young Tumor-Infiltrating Lymphocyte Therapy and Aldesleukin after Combination Chemotherapy in Treating Patients with Non-small Cell Lung Cancer That Is Metastatic or Cannot Be Removed by Surgery

    This phase II trial studies how well young tumor-infiltrating lymphocyte therapy and aldesleukin work after combination chemotherapy in treating patients with non-small cell lung cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery. Tumor-infiltrating lymphocytes (TIL) are white blood cells taken from the patient's tumor that are grown in the laboratory and they may stimulate the immune system in killing more tumor cells. Aldesleukin may help TIL cells to stay alive longer to kill tumor cells. Cyclophosphamide and fludarabine phosphate are chemotherapy drugs that temporarily suppress the immune system and they may also help TIL to survive longer in the body to kill tumor cells.
    Location: 2 locations

  • Tumor Infiltrating Lymphocytes, Aldesleukin, Chemotherapy, and Pembrolizumab in Treating Patients with Metastatic Melanoma

    This phase II trial studies the side effects and how well tumor infiltrating lymphocytes, aldesleukin, chemotherapy, and pembrolizumab work in treating patients with melanoma that has spread to other parts of the body. Doctors have developed an experimental therapy that involves taking cells called lymphocytes from the patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient, called young tumor infiltrating lymphocytes. Before receiving the cells, the patients receive chemotherapy comprising cyclophosphamide and fludarabine phosphate, to temporarily suppress the immune system to improve the chances that the tumor fighting cells will be able to survive in the body. After the cells are given, the patients receive aldesleukin to help the tumor fighting cells stay alive longer. Treating white blood cells with aldesleukin in the laboratory may help the white blood cells kill more tumor cells when they are put back in the body. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving tumor infiltrating lymphocytes, aldesleukin, chemotherapy, and pembrolizumab may work better in treating patients with metastatic melanoma.
    Location: 2 locations

  • Risk-Directed Therapy in Treating Young Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

    This phase II trial studies how well risk directed therapy works in treating younger patients with acute lymphoblastic leukemia that has returned or does not responded to treatment. Giving chemotherapy before a donor peripheral blood stem cell 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 and natural killer 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: 2 locations

  • Genetically Engineered T Cells and Low-Dose Aldesleukin After Combination Chemotherapy in Treating Patients With Metastatic Melanoma

    This phase I trial studies the side effects and best dose of genetically engineered T cells when given together with low-dose aldesleukin after combination chemotherapy in treating patients with metastatic melanoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill tumor cells. Aldesleukin may stimulate the white blood cells to kill melanoma cells. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving genetically engineered T cells and aldesleukin after combination chemotherapy may be an effective treatment for melanoma.
    Location: 2 locations

  • Genetically Engineered Lymphocytes in Treating Patients with Metastatic Cancer or Cancer That Cannot Be Removed by Surgery Receiving Chemotherapy and Aldesleukin

    This phase I / II trial studies the side effects and best dose of genetically engineered lymphocytes and to see how well it works in treating patients with cancer that has spread to other parts of the body or cancer that cannot be removed by surgery receiving chemotherapy and aldesleukin. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells.
    Location: 2 locations

  • Hydroxychloroquine and Aldesleukin in Treating Patients With Metastatic Kidney Cancer

    The main goal of this research study is to determine whether treating patients with renal cell cancer with the study drug (hydroxychloroquine) along with the IL-2 (aldesleukin) can make the cancer easier to kill and eliminate. Another goal is to see how the study drug affects the body’s immune cells which fight cancer cells.
    Location: 3 locations

  • Tumor Infiltrating Lymphocytes, Aldesleukin, and Pembrolizumab after Chemotherapy in Treating Patients with Metastatic Cancers

    This phase II trial studies how well tumor infiltrating lymphocytes, aldesleukin, and pembrolizumab work after chemotherapy in treating patients with cancers that has spread to other parts of the body (metastatic). Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Aldesleukin may stimulate lymphocytes to kill tumor cells. Treating lymphocytes with aldesleukin in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body after chemotherapy.
    Location: 2 locations

  • Nivolumab, Tumor Infiltrating Lymphocytes, Chemotherapy, and Aldesleukin in Treating Patients with Recurrent or Stage IV Non-small Lung Cancer

    This pilot phase I trial studies the side effects of nivolumab, tumor infiltrating lymphocytes, chemotherapy, and aldesleukin in treating patients with non-small lung cancer that is stage IV or has come back after period of improvement. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Tumor infiltrating lymphocytes involve the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes protect the body from viral infections, help other cells fight bacterial and fungal infections, produce antibodies, fight cancers, and coordinate the activities of other cells in the immune system. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, 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. Aldesleukin may help the body respond to treatment on the immune system. Giving nivolumab, tumor infiltrating lymphocytes, chemotherapy, and aldesleukin may work better in treating patients with non-small lung cancer.
    Location: 2 locations

  • Fludarabine, Cyclophosphamide, FATE-NK100 and Aldesleukin in Treating Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase I trial studies the side effects and the best dose of allogeneic CD3- CD19- CD57+ NKG2C+ NK cells FATE-NK100 (FATE-NK100) when given together with aldesleukin after fludarabine and cyclophosphamide in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, 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. FATE-NK100, which is made from cells collected from the blood of a relative who is considered a “donor”, may enhance anti-tumor activity. Aldesleukin may stimulate white blood cells including natural killer cells to kill tumor cells. Giving fludarabine, cyclophosphamide, FATE-NK100, and aldesleukin may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • T Cell Immunotherapy and Aldesleukin in Treating Patients with Vulvar High-Grade Intraepithelial Lesions that are HPV-16 Positive and Cannot Be Removed by Surgery

    This phase I trial studies the side effects and best dose of T cell immunotherapy and aldesleukin in treating patients with vulvar high-grade intraepithelial lesions (HSIL) that are human papilloma virus-16 (HPV-16) positive and cannot be removed by surgery. Taking T cells from a patient's blood, genetically modifying them in a laboratory and infusing them back into a patient's blood may help the T cells attack the human papilloma virus. Drugs like aldesleukin may help the immune cells survive longer. Giving T cell immunotherapy with aldesleukin may cure vulvar HSIL caused by HPV-16.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Anti-KRAS G12V Peripheral Blood Lymphocytes, Chemotherapy, and Aldesleukin in Treating Patients with KRAS G12V Positive and HLA-A*1101 Positive Cancer

    This phase I / II trial studies the best dose and side effects of anti-KRAS G12V peripheral blood lymphocytes, chemotherapy, and aldesleukin, and to see how well they work in treating patients with KRAS G12V positive and HLA-A*1101 positive cancer. Treatment with anti-KRAS G12V peripheral blood lymphocytes involves taking white blood cells called lymphocytes, selecting a specific type of white blood cell to grow in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack the cancer cells, and then giving the cells back. Drugs used in chemotherapy, such as cyclophosphamide 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. Aldesleukin may stimulate white blood cells to kill cancer cells. Giving anti-KRAS G12V peripheral blood lymphocytes, chemotherapy, and aldesleukin may work better in treating patients with KRAS G12V positive and HLA-A*1101 positive cancer.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • FATE-NK100 Donor Natural Killer Cells, Aldesleukin, and Combination Chemotherapy in Treating Patients with Refractory or Relapsed Acute Myeloid Leukemia

    This phase I trial studies the side effects and best dose of FATE-NK100 donor natural killer (NK) cells when given together with aldesleukin and combination chemotherapy in treating patients with acute myeloid leukemia that does not respond to treatment or has come back. The FATE-NK100 NK cell product is made from white blood cells collected from a related donor who is has been exposed to cytomegalovirus (CMV). These “adaptive” NK cells may have more potent anti-cancer killing. Aldesleukin may help FATE-NK100 cells expand and survive in the blood and bone marrow. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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 FATE-NK100 donor natural killer cells together with aldesleukin and combination chemotherapy may work better in treating patients with acute myeloid leukemia.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Extracorporeal Photopheresis and Low Dose Aldesleukin in Treating Patients with Steroid Refractory Chronic Graft-Versus-Host Disease

    This phase II trial studies how well extracorporeal photopheresis and low dose aldesleukin (interleukin-2) work in treating patients with chronic graft-versus-host disease (cGVHD) that does not respond to treatment with steroid. In graft-vs-host disease, patients have a small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to control the immune system. Extracorporeal photopheresis is a procedure where patient's blood is removed and treated with ultraviolet light and drugs that become active when exposed to light. The treated blood is then returned to the patient and may be effective in increasing T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be effective improving GVHD symptoms.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Aldesleukin and Nivolumab in Treating Patients with Metastatic Kidney Cancer

    This phase Ib / II trial studies the side effects of aldesleukin and nivolumab and to see how well they work in treating patients with kidney cancer that has spread from where it started to other places in the body. Aldesleukin may stimulate white blood cells including natural killer cells to kill kidney cancer cells. Monoclonal antibodies, such as nivolumab, block tumor growth in different ways by targeting certain cells. Giving aldesleukin and nivolumab may work better in treating patients with kidney cancer.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • High Dose Aldesleukin and Pembrolizumab in Treating Patients with Metastatic Kidney Cancer

    This phase II trial studies how well high dose aldesleukin and pembrolizumab work in treating patients with kidney cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as aldesleukin, 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. Monoclonal antibodies, such as pembrolizumab, block tumor growth in different ways by targeting certain cells. Giving aldesleukin and pembrolizumab may work better in treating patients with kidney cancer.
    Location: Moffitt Cancer Center, Tampa, Florida

  • T-Cell Receptor Gene Therapy Targeting HPV-16 E7 with or without Pembrolizumab in Treating Patients with Metastatic, Refractory, or Recurrent HPV-Related Cancers

    This phase I trial studies the side effects and best dose of T-cell receptor gene therapy targeting human papillomavirus (HPV)-16 E7 when given together with pembrolizumab in treating patients with HPV-related cancers that have spread to other parts of the body, do not respond to treatment, or have come back. Placing T-cell receptors targeting HPV-16 E7 into white blood cells may help the body build an immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving T-cell receptor gene therapy targeting HPV-16 E7 with or without pembrolizumab may work better in treating patients with HPV-related cancers.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Anti-CD70 Peripheral Blood Lymphocytes in Treating Patients with CD70 Expressing Solid Tumors That Cannot Be Removed by Surgery

    This phase I / II trial studies the safety and best dose of anti-human (h)CD70-chimeric antigen receptor (CAR) retroviral vector-transduced autologous peripheral blood lymphocytes (PBLs) (anti-CD70 peripheral blood lymphocytes) in treating patients with CD70 expressing solid tumors that cannot be removed by surgery. Peripheral blood lymphocytes are special infection fighting blood cells. The cells given in this study will come from the patient and will be genetically modified so that they are able to recognize a molecule called CD70. CD70 is expressed on the surface of many types of tumor cells. Giving modified tumor fighting cells, such as anti-CD70 peripheral blood lymphocytes, back to the patient may cause tumors to shrink.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • High Dose Aldesleukin in Treating Patients with Recurrent Stage III-IV Melanoma That Cannot Be Removed by Surgery

    This phase II trial studies how well high dose aldesleukin works in treating patients with stage III-IV melanoma that has come back and cannot be removed by surgery. Aldesleukin may stimulate white blood cells to kill melanoma cells.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients with Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1

    This phase I trial studies the side effects and the best dose of nivolumab when given together with gene-modified T cells and vaccine therapy in treating patients with solid tumors that express the cancer-testes antigen NY-ESO-1 gene AND have spread from where it started to nearby tissue or lymph nodes (locally advanced) or distant organs (stage IV). T cells are a special type of white blood cells (immune cell) that have the ability to kill cancer cells. Nivolumab may block PD-1 which is found on T cells and help the immune system kill cancer cells. Placing a modified gene for the NY-ESO-1 T cell receptor (TCR) into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Dendritic cells are another type of blood cell that can teach other cells in the body to look for cancer cells and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune system to target cancer cells expressing that protein, and further help the T cells attack cancer. Giving nivolumab together with gene-modified T-cells and dendritic cell vaccine may teach the immune system to recognize and kill cancer cells that express NY-ESO-1.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Anti-ESO (cancer / test antigen) mTCR-transduced Autologous Peripheral Blood Lymphocytes and Combination Chemotherapy in Treating Patients with Metastatic Cancer That Expresses NY-ESO-1

    This pilot clinical trial studies the side effects of anti-ESO (cancer / test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer that has spread to other places in the body (metastatic) and expresses the gene NY-ESO-1. Donor white blood cells that are treated in the laboratory with anti-cluster of differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as cyclophosphamide 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 more than one drug (combination chemotherapy) may kill more cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to kill metastatic cancer cells. Giving anti-ESO (cancer / test antigen) mTCR-transduced autologous peripheral blood lymphocytes together with combination chemotherapy and aldesleukin may kill more cancer cells.
    Location: Montefiore Medical Center-Weiler Hospital, Bronx, New York

  • Laboratory-Treated (Central Memory / Naïve) CD8+ T Cells in Treating Patients with Newly Diagnosed or Relapsed Acute Myeloid Leukemia

    This phase I / II trial studies the side effects of laboratory-treated (central memory / naive) cluster of differentiation 8+ T cells (autologous Wilms tumor [WT]1-T cell receptor [TCRc]4 gene-transduced CD8-positive central memory T-cells [TCM] / naïve T cells [TN] lymphocytes) and how well it works in treating patients with acute myeloid leukemia that is newly diagnosed or has come back. Genetically modified therapies, such as autologous WT1-TCRc4 gene-transduced CD8-positive TCM / TN lymphocytes, are taken from a patient's blood, modified in the laboratory so they specifically may kill cancer cells with a protein called WT1, and safely given back to the patient. The "genetically modified" T-cells have genes added in the laboratory to allow them to recognize leukemia cells that express WT1 and kill them.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington


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