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Kaposi Sarcoma clinical trials

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NCT ID: NCT04902443 Recruiting - Kaposi Sarcoma Clinical Trials

Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV

Start date: December 10, 2021
Phase: Phase 1
Study type: Interventional

Background: Less toxic and more effective treatments are needed for cancers caused by viruses. These cancers include Hodgkin and non-Hodgkin lymphoma, hepatocellular carcinoma, head and neck cancer, nasopharyngeal carcinoma, gastric cancer, anal cancer, cervical cancer, vaginal cancer, vulvar cancer, penile cancer, Merkel cell carcinoma, Kaposi sarcoma, and leiomyosarcoma. Researchers want to see if a combination of drugs can help. Objective: To find a safe dose of pomalidomide plus nivolumab in people with cancers caused by viruses. Eligibility: Adults ages 18 or older who have cancers caused by Epstein Barr virus (EBV), human herpes virus 8/Kaposi sarcoma herpesvirus (HHV8/KSHV), human papilloma virus (HPV), hepatitis B or C virus (HBV/HCV), and Merkel cell polyomavirus (MCPyV) that have not responded to previous treatments or have relapsed, or in adults who do not want to have surgery because of disfigurement or other risks. Adults who have HIV with any CD4 T cell count are eligible. Design: Participants will be screened with blood and urine tests, scans, and heart tests. They will have a physical exam. Their ability to perform normal daily activities will be assessed. They may have a tumor biopsy. Treatment will be given in 28-day cycles. Participants will take pomalidomide as a tablet by mouth for 21 days of each cycle, for up to 24 cycles. They will get nivolumab by intravenous infusion once each cycle. They will take an aspirin each day until 30 days after their last dose of the study drugs. Participants will keep a pill diary. They will bring it to their study visit at the end of each cycle. At these visits, some screening tests will be repeated. Participants with Kaposi sarcoma will have pictures taken of their lesions. Participants will give blood and saliva samples for research. They may have optional anal and/or cervical swabs. They may have optional biopsies. Participants will have a follow-up visit 30 days after they stop taking the study drugs, then every month for 100 days. Some screening tests will be repeated. Then they may by contacted by phone every 3 months for 9 months, and then every 6 months thereafter....

NCT ID: NCT04893018 Terminated - HIV Infection Clinical Trials

NT-I7 for Kaposi Sarcoma in Patients With or Without HIV

Start date: May 23, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial studies the best dose and effects of NT-I7 in treating Kaposi sarcoma in patients with or without HIV. NT-I7 works by using a patient's immune system to fight cancer. It is made in a laboratory and is used to boost, direct, or restore the body's natural defenses against cancer. NT-I7 may work better in treating Kaposi sarcoma.

NCT ID: NCT04742387 Active, not recruiting - Kaposi Sarcoma Clinical Trials

Assessment of Bone Mineral Density in People Living With HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis

Start date: February 4, 2021
Phase:
Study type: Observational

Background: Some people with human immunodeficiency virus (HIV) are on antiretroviral therapy (ART). Their cells have shown to age faster than expected. This puts them at higher risk for a range of age-related diseases about 10 years sooner than people who do not have HIV. Low bone mineral density (BMD) is common in people with HIV. This means their risk of fractures is increased. People with HIV also have a higher risk for cancers caused by Kaposi's sarcoma herpesvirus (KSHV) than people who do not have HIV. Much of the data on bone loss related to cancer and cancer treatments has been gathered from people who do not have HIV. Researchers want to learn more about the rate of bone loss in people with HIV/AIDS and KSHV associated cancers. Objective: To learn the factors that are linked to BMD loss in people with HIV and KSHV associated cancers from imaging performed as part of NIH studies. Eligibility: Adults with HIV and Kaposi s sarcoma who got ART and cancer chemotherapy at NIH from 1/1/2005 to 12/1/2020. Design: Participants' records will be chosen from studies that were conducted from 1/1/2005 to 12/1/2020. This study will include participants who had at least 2 CT scans. Some participants may have opted out of the future use of their data. If so, their records will not be used. This study will use data collected at NIH. Data taken from CT scans will be used to measure BMD. Study results may be published. This study will last about 2 years.

NCT ID: NCT04305691 Recruiting - Kaposi Sarcoma Clinical Trials

Trial of Ixazomib for Kaposi Sarcoma

Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT04303117 Recruiting - Kaposi Sarcoma Clinical Trials

NHS-IL12 Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma

Start date: July 13, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Kaposi sarcoma (KS) tumors grow on the skin, lymph nodes, lungs, bone, and gastrointestinal tract. KS often affects people with immune deficiencies, such as among people living with HIV or those with prior history of transplant. Researchers want to see if 2 non-chemotherapy drugs can help people with KS. NHS-IL12 triggers the immune system to fight tumors. M7824 blocks the pathways that cancer cells use to stop the immune system from fighting tumors. Objective: To learn if giving NHS-IL12 alone or with M7824 could help the immune system fight KS tumors. Eligibility: People 18 and older with KS that has been treated with chemotherapy or immunotherapy Design: Participants will be screened with some or all of the following: medical history physical exam chest X-ray computed tomography scan blood and urine tests electrocardiogram and echocardiogram skin KS lesion biopsy lung exam gastrointestinal exam All participants will get NHS-IL12 every 4 weeks for up to 96 weeks (or 24cycles). It is injected under the skin. Some participants will also get M7824 every 2 weeks for up to 96 weeks (or 24cycles). It is given through a plastic tube that is put in an arm vein. Participants will complete questionnaires about how KS affects their quality of life. Their KS lesions will be measured and photographed. They will repeat some of the screening tests. They will give saliva samples or additional tissue samples. They will have a lung function test. Their ability to perform their normal activities will be assessed. The treatment duration is up to 96 weeks (or 24cycles) with an option to take NHS-IL12 and/or M7824 until the KS tumors are not responding, or you develop unacceptable side effects. Participants will have follow-up visits 7 and 30 days after treatment ends, then every 3 to 6 months for the next 18 months, then once a year for 3 years.

NCT ID: NCT04065152 Recruiting - Kaposi Sarcoma Clinical Trials

Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma

KAPVEC
Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

Kaposi Sarcoma (KS) is a lymphangioproliferation associated with human herpes virus 8 (HHV8) promoted by immunosuppression. HIV-related KS and iatrogenic posttransplantation KS are treated by immune restoration, in association with local or systemic therapies as chemotherapies if required. Conversely in classic and endemic KS, the underlying relative immunosuppression cannot be directly targeted. Treatment is poorly codified, mostly based on surgery or radiotherapy for localized KS. Most aggressive forms with visceral involvement are treated with chemotherapies or interferon, which give at best 30-60% of transient responses and may not be well tolerated in elderly patients. Talimogene laherparepvec is the first oncolytic immunotherapy approved by the FDA, in metastatic or unresectable melanoma with injectable nodal or cutaneous lesions. It is designed to induce tumor regression of injected lesions through direct lytic effects, and of uninjected lesions through induction of systemic antitumor immunity. In Merkel cell carcinoma (MCC), another virus-induced tumor, treatment with PD-1/PD-L1 axis inhibitors have proven efficacy, thus providing a proof of principle that immunotherapy could be effective in virus-induced tumors. Two cases of metastatic MCC successfully treated with talimogene laherparepvec were recently reported, suggesting that talimogene laherparepvec may also be an effective therapeutic option. Considering the high immunogenicity of viral epitopes in KS tumors, the role of the immune evasion in the development of KS, and the cutaneous manifestations (>90% of patients) that can be easily injected, classic and endemic KS is a good tumor model to be targeted with talimogene laherparepvec. The main objective is to assess whether talimogene laherparepvec is clinically inactive (partial+complete response probability π0<10%) or truly active (partial+complete response probability π1>40%) in classic and endemic Kaposi sarcoma.

NCT ID: NCT03993106 Recruiting - Kaposi Sarcoma Clinical Trials

A Study of sEphB4-HSA in Kaposi Sarcoma

Start date: September 17, 2020
Phase: Phase 2
Study type: Interventional

sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to learn if sEphB4-HSA will decrease the number or size of Kaposi sarcoma lesions in people.

NCT ID: NCT03469804 Recruiting - Kaposi Sarcoma Clinical Trials

Phase II Multicentric Study of Pembrolizumab in Classic or Endemic Kaposi's Sarcoma

KAPKEY
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies. Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples have been recently reported. Our experience in classical and endemic KS supports the role of this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS lesions. In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and endemic KS.

NCT ID: NCT03404297 Completed - Kaposi Sarcoma Clinical Trials

Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The efficacy of locally sourced compression therapy in the management of chronic leg ulcers and Kaposi Sarcoma in western Kenya will be studied in a rural setting

NCT ID: NCT03316274 Completed - HIV/AIDS Clinical Trials

Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma

Start date: May 7, 2018
Phase: Early Phase 1
Study type: Interventional

There is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS). Radiation and injection of vinblastine both have side effects that may not be acceptable. Nivolumab has been used to treat more extensive KS when given intravenously. This is, to the investigators' knowledge, the first trial to see if nivolumab can be used as treatment in the form of an injection into KS lesion.