Clinical Trials Using Aldesleukin

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 62
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  • Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients with Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma

    This partially randomized phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better in treating younger patients with neuroblastoma or ganglioneuroblastoma.
    Location: 23 locations

  • 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: 11 locations

  • A Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion With or Without 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: 5 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

  • CISH Inactivated Tumor Infiltrating Lymphocytes in Treating Participants with Refractory Metastatic Gastrointestinal Epithelial Cancer

    This phase I / II trial studies the side effects of CISH inactivated tumor infiltrating lymphocytes and to see how well it works in treating participants with gastrointestinal epithelial cancer that has spread to other places in the body and that does not respond to treatment. Tumor infiltrating lymphocyte therapy involves taking cells called lymphocytes from participants' tumors, growing them in the laboratory in large numbers, selecting the cells that contain tumor specific mutations, and then removing the CISH gene that may help shrink tumors in participants with refractory metastatic gastrointestinal epithelial cancer.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • TCR Genetically Engineered PBMC and PBSC after Melphalan Conditioning Regimen in Treating Participants with Relapsed and Refractory Multiple Myeloma

    This phase I trial studies the side effects of NY-ESO-1 TCR engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after melphalan conditioning regimen in treating participants with multiple myeloma that has come back or does not respond to treatment. The melphalan conditioning chemotherapy makes room in the patient’s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer. Giving NY-ESO-1 TCR PBMC and PBSC after melphalan may work better at treating multiple myeloma.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • LN-145 in Treating Participants with Relapsed or Refractory Ovarian Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas

    This phase II trial studies how well autologous tumor infiltrating lymphocytes LN-145 (LN-145) works in treating participants with ovarian cancer, osteosarcoma, or other bone and soft tissue sarcomas that do not respond to treatment (refractory) or that has come back (relapsed). LN-145 is made by collecting and growing specialized white blood cells (called T-cells) that are collected from the participants tumor. The T cells may specifically recognize, target and kill the tumor cells.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Transduced Peripheral Blood Lymphocytes in treating Participants with Metastatic Tumors

    This phase II trial studies how well autologous peripheral blood lymphocytes (PBLs) retrovirally-transduced with T cell receptors (TCRs) targeting neoantigens work in treating participants with tumors that have spread to the other places in the body. White blood cells (lymphocytes) taken from participants tumors are treated and grown in the laboratory to recognize specific mutations and attack only tumor cells with those mutations. This may improve the body's ability to fight the cancer.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine)

    The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR after a Myeloablative Conditioning Regimen to Treat Patients with Advanced Cancer

    This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1 TCR engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after a myeloablative conditioning regimen to treat patients with cancer that has spread to other parts of the body. The conditioning chemotherapy makes room in the patient’s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • 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

  • Genetically Modified T Cells and Decitabine in Treating Patients with Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    This phase I trial studies the side effects of genetically modified T cells and decitabine in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back or has not responded to previous treatments. White blood cells called T cells are collected via a process called leukapheresis, genetically modified to recognize and attack tumor cells, then given back to the patient. Decitabine may induce and increase the amount of the target protein NY-ESO-1 available on the surface of tumor cells. Giving genetically modified T cells and decitabine may kill more tumor cells.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • 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


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