BAY 43-9006 (Sorafenib) to Treat Patients With Kaposi's Sarcoma
Kaposi's SarcomaHHV-81 moreBackground: Kaposi's sarcoma (KS) is a disease in which cancer cells are found in the tissues under the skin or mucous membranes that line the mouth, nose, and anus. KS causes red or purple patches (lesions) on the skin or mucous membranes and spreads to other organs in the body, such as the lungs, liver, or intestinal tract. BAY 43-9006 inhibits the activity of several proteins or protein receptors in cells that are thought to be important to the progression of KS. Blocking these mechanisms may cause KS to get better. Objectives: To learn about the toxicity and blood levels of BAY 43-9006 in people with KS who are and are not taking the anti-retroviral drug ritonavir. To look for evidence of a beneficial treatment effect of BAY 43-9006 Eligibility: Adults with confirmed KS, both HIV-positive and HIV-negative. Patients must have either 1) at least five measurable KS lesions with no previous local therapy, or 2) other measurable non-skin disease that permits evaluation of a response to treatment. Design: Patients are randomly assigned to a specific dose of BAY 43-9006. They take the drug by mouth either once or twice daily, depending on their dose group, for up to 54 weeks. Drug blood levels are determined after patients have been taking BAY 43-9006 for 1 to 2 weeks by blood collections immediately before the dose and at 1, 2, 4, 8, 12, 16 and 24 hours after the dose. Patients are evaluated every 3 weeks with review of a medication diary, interview about drug side effects, physical examination, and assessment of KS lesions. KS lesions are photographed on entering the study and at other time points during the study. CD4 cell counts and HIV viral load are tested every 12 weeks. Biopsies are done at the start of the study, on day 15, and if it appears that all of the lesions have resolved. Other procedures, such as CT or MRI scans, may be done if medically indicated.
A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus...
Kaposi SarcomaClassic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8 (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion, all patients will have at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%. Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3 patients responded, 15 patients will be accrued in a second stage.
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized...
Kaposi SarcomaHuman Immunodeficiency Virus1 moreKaposi sarcoma (KS) has an unpredictable course, patients with disseminated KS starting combined Antiretroviral Therapy can develop Immune Reconstitution Syndrome (IRIS), with a severe clinical presentation and high mortality (severe-IRIS-KS). The objective of this study is to evaluate the presence of Severe IRIS-KS and it´s attributable mortality in patients with AIDS and disseminated KS with the use of valganciclovir prior to the initiation of cART compared with the standard management of immediate cART initiation.
Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
Chronic Leg UlcerKaposi Sarcoma1 moreThe 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
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe...
AIDS-related Kaposi's SarcomaOpen-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study will be conducted at a single site, the Parirenyatwa Hospital KS Clinic. Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in response to treatment with antiretroviral therapy and to investigate whether clinical resolution of KS is associated with suppression of KSHV replication. Step 2 was developed to then evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen. Step 3 was included to evaluate the clinical, immunological, and virological effects of intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have virological failure on an all NRTI regimen.
Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma
AIDS-Related Kaposi SarcomaHIV Infection1 moreThis pilot, phase I trial studies the side effects and best dose of bortezomib in treating patients with acquired immune deficiency syndrome (AIDS)-related Kaposi sarcoma that has come back or has not responded to treatment. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
SarcomaRATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells. PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin patch works in treating patients with Kaposi's sarcoma.
Treatment of Classical Non-HIV-Related Kaposi's Sarcoma With the Antiviral Drug Indinavir
Classical Kaposi's SarcomaRecent studies have described a reduced incidence or the regression of Kaposi's sarcoma (KS) in HIV-infected patients treated with the highly active anti-retroviral therapy (HAART) that contains at least one inhibitor of the HIV protease (HIV-PI) such as Indinavir. Experimental studies have shown that part of the anti-KS actions of HIV-PI are not related to their antiretroviral actions, but, at least in part, to their capability of blocking angiogenesis and tumor growth. This study will be conducted on HIV-negative (classical) KS patients to prove that Indinavir has anti-angiogenic and anti-KS effects in humans independently of its antiretroviral activity.
SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma
SarcomaRATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.
BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma
SarcomaPhase I/II trial to study the effectiveness of BMS-275291 in treating patients who have HIV-related Kaposi's sarcoma. Drugs such as BMS-275291 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.