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Sarcoma, Kaposi clinical trials

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NCT ID: NCT00444379 Completed - HIV Infections Clinical Trials

Anti-Retrovirals for Kaposi's Sarcoma

ARKS
Start date: April 2007
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine whether a protease inhibitor-based antiretroviral regimen is more efficacious than a non-nucleoside reverse transcriptase inhibitor-based antiretroviral regimen in promoting the regression of KS tumor burden in persons with AIDS-related KS in Africa.

NCT ID: NCT00395278 Completed - HIV Infection Clinical Trials

Development of Serologic Assays for Human Herpes Virus-8

Start date: October 30, 2006
Phase:
Study type: Observational

Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.

NCT ID: NCT00380770 Completed - HIV Clinical Trials

HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT

KAART
Start date: January 2003
Phase: Phase 4
Study type: Interventional

Kaposi's sarcoma (KS)is the commonest malignancy associated with HIV/AIDS. Therapy for this cancer, which causes substantial morbidity, is suboptimal in resource poor settings. The reasons for this are: advanced state of immunosuppression when patients present for clinical care, concomitant opportunistic infections, non- availability of antiretroviral therapy (ART), non-availability and toxicity of chemotherapy (CXT), when available, in patients with full blown AIDS, prohibitive costs of bone marrow support and fiscal constraints in resource poor settings. A recent Cochrane Review assessed the effectiveness of current therapeutic regimens for HIV KS, with a focus on options available in resource poor settings. The major selection criteria for this review were randomized controlled trials for HIV KS in adults. The main conclusions were that data from randomized controlled trials on effective treatments for HIV KS are sparse, particularly among people who are also taking highly active antiretroviral therapy (HAART). Alitretinoin gel is effective for therapy of cutaneous lesions, pegylated liposomal doxorubicin is effective for advanced KS and radiotherapy is effective for treating cutaneous lesions. Apart from the randomized trial of radiotherapy, no trials applicable to developing settings were identified. Therapy of HIV KS in developing countries thus remains unanswered. The authors concluded that therapies discussed in the review are unlikely to be available or affordable in developing countries where the bulk of HIV infection and KS occur, apart from radiotherapy at a few tertiary centers. However, recent changes in pricing due to the global alliance and access initiatives mean that HAART is likely to be more available and accessible to developing countries in the near future. South Africa now has committed to this at cabinet level and had a task force to address this issue. HAART has been proposed as therapy for HIV KS on the basis of restoring immune competence and minimizing the HIV tat drive to KS formation. It also improves immunologic control of HHV 8 possibly through interrupting the HIV-1- HHV-8 interaction. There has been only one randomised trial conducted in Spain which compared HAART to the combination of HAART and CXT. There is to date no prospective, randomised controlled trial which compares the efficacy of HAART to the standard of care in HIV KS in Africa.

NCT ID: NCT00362310 Completed - Clinical trials for Classical Kaposi's Sarcoma

Treatment of Classical Non-HIV-Related Kaposi's Sarcoma With the Antiviral Drug Indinavir

Start date: June 2003
Phase: Phase 2
Study type: Interventional

Recent 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.

NCT ID: NCT00339937 Completed - Clinical trials for Kaposi s Sarcoma (KS)

Studies of Human Herpesvirus 8 and Kaposi's Sarcoma in Sicily

Start date: July 30, 1998
Phase:
Study type: Observational

A series of studies will be conducted in Sicily by a collaborative team from the U.S. National Cancer Institute and the University of Palermo to better understand the prevalence and risk factors for the newly discovered human herpes virus 8 (HHV8) and Kaposi s sarcoma (KS), which may be a consequence of HHV8 infection. There are four short-term projects: 1. To determine HHV8 seroprevalence in extant, unlinked sera from informative groups, including homosexual men, persons with sexually transmitted diseases, and in general population groups, particularly the elderly. In addition, HHV8 prevalence and other serological studies may be determined among other adults, particularly those who may be recruited for future studies and those likely to enhance understanding of HHV8 serology. 2. To identify a pediatric syndrome that might be associated with HHV8 infection, HHV8 seroprevalence will be determined in sera from hospitalized children with a wide range of clinical conditions. 3. To determine HHV8 seroprevalence in various regions of Italy and by HLA Class II groups that have been linked to increased (HLA-DR5) or decreased (HLA-DR3) risk of KS, using extant, unlinked sera and data from volunteer bone marrow donors. 4. To conduct a case control study that will identify risk factors for KS among persons who are infected with HHV8 and who manifest anti-HHV8 latent antibodies. The results of these projects will be summarized for publication in the medical and scientific literature and for the design and prioritization of related projects in the future.

NCT ID: NCT00339326 Completed - Kaposi's Sarcoma Clinical Trials

Risk Factors for Non-HIV-Related Kaposi s Sarcoma

Start date: September 1, 2002
Phase:
Study type: Observational

This study will try to identify risk factors for Kaposi s sarcoma, a rare skin cancer, and to understand the role of the KSHV virus in development of the disease. All native-born Italians 21 years of age or older residing in Sicily from July 1, 2002 through June 30, 2005 who have Kaposi s sarcoma not related to HIV infection may be eligible for this study. Healthy control subjects will also be enrolled. All participants will be interviewed about their childhood, jobs, habits, medical conditions, and treatments. They also will provide a blood sample and a saliva sample, obtained by swishing a mouthwash for 45 seconds and spitting it into a container. Blood will be tested for two viruses KSHV and HIV that are related to Kapsosi s sarcoma. The KSHV virus is newly discovered and not well understood. In general, a positive KSHV test probably means an infection with the virus has occurred in the past, but not necessarily that disease has developed. HIV is the virus that causes AIDS. People with AIDS have a high risk of Kapsosi s sarcoma. Although HIV and AIDS are very rare among older adults in Sicily, the presence of HIV must be ruled out in order to understand how KSHV is related to Kapsosi s sarcoma. The blood may also be used to measure immunity (the body s defense against infection and cancer) and for genetic studies to help discover why Kapsosi s sarcoma occurs.

NCT ID: NCT00295984 Completed - Sarcoma Clinical Trials

Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Start date: March 2006
Phase: Phase 2
Study type: Interventional

RATIONALE: 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.

NCT ID: NCT00096538 Completed - Sarcoma Clinical Trials

Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma

Start date: April 2004
Phase: N/A
Study type: Interventional

RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma. PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposi's sarcoma.

NCT ID: NCT00090987 Completed - Sarcoma Clinical Trials

Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma

Start date: June 2005
Phase: Phase 2
Study type: Interventional

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposi's sarcoma.

NCT ID: NCT00075777 Completed - Sarcoma Clinical Trials

Valproic Acid in Treating Patients With Kaposi's Sarcoma

Start date: February 2005
Phase: N/A
Study type: Interventional

RATIONALE: Valproic acid may help stop the growth of Kaposi's sarcoma cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related Kaposi's sarcoma.