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 61
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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: 92 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: 10 locations

  • 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: 4 locations

  • OKT3 / Humanized 3F8 Bispecific Antibody-Activated T Lymphocytes, Aldesleukin, and Sargramostim in Treating Younger Patients with GD2-Positive Metastatic, Recurrent or Refractory Solid Tumors

    This phase I / II trial studies the side effects and best dose of OKT3 / humanized 3F8 bispecific antibody-activated T lymphocytes with given together with aldesleukin and sargramostim and to see how well they work in treating younger patients with disialoganglioside GD2 (GD2)-positive solid tumors that have spread to other parts of the body (metastatic), have come back (recurrent), or do not respond to treatment (refractory). Biological therapies, such as OKT3 / humanized 3F8 bispecific antibody-activated T lymphocytes, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Aldesleukin and sargramostim may stimulate white blood cells to kill tumor cells. Giving white blood cells that have been activated by OKT3 / humanized 3F8 bispecific antibody-activated T lymphocytes with aldesleukin and sargramostim may kill more tumor cells.
    Location: 4 locations

  • Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients with Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant

    This phase II trial studies the side effects and how well dinutuximab and sargramostim work with combination chemotherapy in patients with high-risk neuroblastoma undergoing stem cell transplant. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Sargramostim helps the body produce normal infection-fighting white blood cells. Giving chemotherapy before a stem cell transplant, with drugs such as cisplatin, etoposide, vincristine, doxorubicin, cyclophosphamide, thiotepa, melphalan, etoposide, carboplatin, topotecan, and isotretinoin, helps kill any cancer cells that are in the body and helps make room in a patient's bone marrow for new blood-forming cells (stem cells). Giving dinutuximab and sargramostim with combination chemotherapy may work better in treating patients with high-risk neuroblastoma undergoing stem cell transplant.
    Location: 3 locations

  • Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

    Background: - The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 400 patients with melanoma. - In this trial, we are determining if there is a difference in the response between patients who have received prior anti-PD1 treatment to those who have not received this prior ant-PD1 treatment. Objectives: - To determine if there is a difference in the rate of response between patients who have received prior anti-PD1 and those who have not. Eligibility: - Individuals at least 18 years and less than or equal to 70 years of age who have metastatic melanoma. Design: - Work up stage: Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - Surgery: Surgery or biopsy will be performed to obtain tumor from which to grow white blood cells. White blood cells will be grown from the tumor in the laboratory. - Leukapheresis: Participants will have leukapheresis to collect additional white blood cells. (Leukapheresis is a common procedure which removes only the white blood cells from the patient.) - Treatment: Participants will receive standard dose chemotherapy to prepare their immune system to accept the white blood cells. Participants will receive an infusion of their own white blood cells grown from tumor. They will also receive aldesleukin for up to five days to boost the immune system s response to the white blood cells. They will stay in the hospital for about 4 weeks for the treatment. - Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.
    Location: 2 locations

  • T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer

    Background: The NCI Surgery Branch has developed an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying them, and then giving the cells back to the patient. In a previous study the NCI Surgery Branch used the anti-ESO-1 gene and a type of virus (retrovirus) to make these tumor fighting cells (anti-ESO-1 cells). About half of the patients who received this treatment experienced shrinking of their tumors. In this study, we are using a slightly different method of producing the anti-ESO-1 cells which we hope will be better in making the tumors shrink. Objectives: The purpose of this study is to see if these tumor fighting cells (genetically modified cells) that express the receptor for the ESO-1 molecule on their surface can cause tumors to shrink and to see if this treatment is safe. Eligibility: - Patients 15 years old and older with cancer that has the ESO-1 molecule on their tumors. Design: - Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed - Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells. {Leukapheresis is a common procedure which removes only the white blood cells from the patient.} - Treatment: Once their cells have grown the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-ESO-1 cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. - Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.
    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

  • 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

  • Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

    Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian / endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian / endometrial tumors to shrink and to see if this treatment is safe. Eligibility: - Adults age 18-70 with metastatic digestive tract, urothelial, breast, or ovarian / endometrial cancer who have a tumor that can be safely removed. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
    Location: 2 locations

  • Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients

    Background: A new cancer therapy takes white blood cells from a person, grows them in a lab, genetically changes them, then gives them back to the person. Researchers think this may help attack tumors in people with certain cancers. It is called gene transfer using anti-KRAS G12D mTCR cells. Objective: To see if anti-KRAS G12D mTCR cells are safe and cause tumors to shrink. Eligibility: Adults ages 18-70 who have cancer with a molecule on the tumors that can be recognized by the study cells Design: Participants will be screened with medical history, physical exam, scans, photography, and heart, lung, and lab tests. An intravenous (IV) catheter will be placed in a large vein in the chest. Participants will have leukapheresis. Blood will be removed through a needle in an arm. A machine will divide the blood and collect white blood cells. The rest of the blood will be returned to the participant through a needle in the other arm. A few weeks later, participants will have a hospital stay. They will: - Get 2 chemotherapy medicines by IV over 5 days. - Get the changed cells through the catheter. Get up to 9 doses of a medicine to help the cells. They may get a shot to stimulate blood cells. - Recover in the hospital for up to 3 weeks. They will provide blood samples. Participants will take an antibiotic for at least 6 months. Participants will have several follow-up visits over 2 years. They will repeat most of the screening tests and may have leukapheresis. Participants blood will be collected for several years.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Genetically engineered cells (NY-ESO-1 TCR engineered T cells and HSCs) after Melphalan Conditioning Regimen in Treating Patients with Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase I trial studies the best dose and side effects of NY-ESO-1 T cell receptor (TCR) engineered T cells and how well they work with NY-ESO-1 TCR engineered hematopoietic stem cells (HSCs) after melphalan conditioning regimen in treating patients with ovarian, fallopian tube, or primary peritoneal cancer 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 and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR T cells 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 engineered T cells and HSCs after melphalan may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
    Location: Roswell Park Cancer Institute, Buffalo, New York

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

    This early phase I trial studies the side effects and how well tumor infiltrating lymphocytes with chemotherapy work in treating patients with melanoma that has spread to other places in the body. Specific cells, such as tumor infiltrating lymphocytes developed from the immune cells found within a patients tumor masses may help to target tumor cells. 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. Giving tumor infiltrating lymphocyte and chemotherapy may work better in treating patients with melanoma.
    Location: Yale University, New Haven, Connecticut

  • 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

  • High Dose Aldesleukin with or without Entinostat in Treating Participants with Metastatic or Unresectable Renal Cell Cancer

    This phase II trial studies how well high dose aldesleukin with or without entinostat work in treating participants with renal cell cancer that has spread to other areas of the body or cannot be removed by surgery. Interleukins are proteins made by white blood cells and other cells in the body that may help regulate immune response. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if high dose aldesleukin with or without entinostat may work better in treating participants with renal cell cancer.
    Location: 5 locations

  • 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

  • TCR-engineered T Cells in Solid Tumors Including NSCLC and HCC Patients

    The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer

    Background: In gene transfer therapy, cells are taken from a person s tumor to isolate mutations. White blood cells are then taken from the person's body, changed with a type of virus to attack the tumor cells, and returned to the person. Objective: To see if gene transfer therapy shrinks tumors. Eligibility: People with certain metastatic cancer for which standard treatments have not worked Design: Participants will complete screening and stages 1-3 under another protocol. Screening includes: Undergoing a biopsy or surgery at the NIH to obtain pieces of tumor in order to grow tumor cells Medical history Physical exam Scans Blood, urine, heart, and lung tests The study has 7 stages: 1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm. An IV catheter will be placed in the chest. 2. Care at home over 6-12 weeks. 3. Stopping therapy for 4-6 weeks while their cells are changed in a lab. 4. Hospital stay for 1 week to get chemotherapy by IV. 5. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer. 6. Recover in the hospital for 1 2 weeks. Participants will get drugs and have blood and urine tests. 7. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • HERV-E TCR Transduced CD8+ / CD34+ T-cells in Treating Patients with Metastatic Clear Cell Renal Cell Cancer

    This phase I trial studies the side effects of HERV-E TCR transduced CD8+ / CD34+ T-cells in treating patients with clear cell renal cell cancer that has spread to other places in the body. HERV-E is a viral molecule of the HERVs family that becomes active in cancer cells and has been found in the surface of kidney tumor cells (not in healthy human normal cells). The incorporation of HERV-E into lymphocytes (T cells) may enable the immune system to recognize and fight kidney cancer cells.
    Location: National Heart Lung and Blood Institute, Bethesda, Maryland

  • Aldesleukin and Pembrolizumab in Treating Patients with Advanced or Metastatic Kidney Cancer

    This phase I trial studies the side effects and best dose of aldesleukin when given together with pembrolizumab in treating patients with kidney cancer that has spread to other parts of the body. Aldesleukin may stimulate white blood cells to kill kidney cancer cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may work better in treating patients with kidney cancer.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • 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

  • Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions

    Background: Vulvar high-grade squamous intraepithelial lesion (HSIL) is caused by infection of the vulva with human papillomavirus (HPV). In a small percentage of cases, vulvar HSIL can turn into cancer. The risk of cancer can be reduced by treating HSIL. A personalized immune treatment might rid the body of HPV infection and thereby cure vulvar HSIL. The immune treatment in this study is called T cell therapy. The cells are E6 TCR T cells. Participants will also get aldesleukin (IL-2) to help the cells last longer. Objective: To find a safe dose of E6 TCR T cells combined with aldesleukin to use in people with vulvar HSIL. Eligibility: Design: Participants will be screened with: Physical exam Medical history Blood, lab, and pregnancy tests Heart tests Chest x-ray Sample of tissue taken from the vulva (biopsy). Participants will have leukapheresis. Blood will be removed by a needle in one arm. A machine removes white blood cells from the blood. The rest of the blood is returned by needle in the other arm. The white blood cells will be changed into E6 TCR T cells and grown in a lab. About 3 weeks later, participants will be admitted to the hospital for about 5 days. They will get the cells through a tube placed in a vein. They will get IL-2 the same way. Participants will recover 1-3 days in the hospital. They will be monitored closely. They will have blood and lab tests. Participants will have follow-up visits with lab tests and a physical exam every few months for 5 years. At some visits they will also have leukapheresis, blood tests, or vulvar biopsy.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland


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