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Soft Tissue Sarcoma

Kaposi Sarcoma

Cases with Kaposi's Sarcoma from Southern Italy.

Sam M Mbulaiteye, M.D.

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.

Persons infected with the Kaposi s sarcoma-associated herpesvirus (KSHV) are at risk for developing Kaposi s sarcoma (KS), but the risk factors for KSHV infection and for KS following infection are not well defined. Classical KS (cKS) occurs without apparent immune deficiency (such as AIDS or an allograft). The proposed study will test specific hypotheses and generate new hypotheses on the risk of cKS among persons who have antibodies against KSHV, on the risk of KSHV seropositivity, and on the risk of active KSHV infection, defined as KSHV viremia or viral shedding in saliva. To do so, 120 incident cases of cKS from throughout Sicily and approximately 1800 persons (15% KSHV seropositive) of similar age, sex, and community size will be asked to participate by providing questionnaire data and blood and saliva specimens. Residual formalin-fixed, paraffin embedded tissue from KS skin biopsies will be available for verification of diagnosis and molecular analyses. Primary hypotheses are focused on host genetic susceptibility, endogenous clinical conditions (such as asthma and allergy), and exogenous exposures (cigarette smoking and contact with certain plants, water and soil) that are postulated to affect KSHV activation, dissemination, and disease induction. The study will have sufficient statistical power to detect factors that increase the risk of KSHV seropositivity by 1.5- to 2-fold, the risk of cKS by 2- to 3-fold, and the risk of KSHV viremia or shedding by 3- to 4-fold.

Risk Factors for Non-HIV-Related Kaposi s Sarcoma

Cofactors for Classical Kaposi's Sarcoma and for Kaposi's Sarcoma-Associated Herpesvirus Infection: A Case-Control Study in Sicily

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antibodies

Immunoglobulins

Mitogens

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks.

15 mg/kg day intravenously on day 1, day 8, then every 3 weeks.

Robert Yarchoan, M.D.

This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth. Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that is produced by the body and is involved in blood vessel growth. Bevacizumab may block the action of VEGF, and thus help shrink KS lesions.

Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and is not life threatening may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, and, if needed, imaging studies to evaluate internal tumors.

Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at a slower infusion rate. Patients will be evaluated with the following tests and procedures:

* Physical examination, assessment of drug side effects, measurement of KS lesions, and photographs of lesions once a week for the first 6 weeks of therapy, and then every 3 weeks.
* cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV) viral load in HIV-positive patients every 12 weeks.
* Biopsies of lesions: upon entering the study, at week 12, and at the time of a response of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or later.
* Additional biopsies, if requested. (Additional biopsies are not required.)
* Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI) scans, if medically indicated.

Patients may continue bevacizumab therapy indefinitely if they are benefiting from it, as long as they have no substantial toxicity or other conditions that would cause them to stop receiving it and the protocol remains open.

BACKGROUND:

This is a phase II study to determine the activity of bevacizumab, a putative antiangiogenic agent, in Kaposi's sarcoma (KS). Bevacizumab is a humanized recombinant antibody to vascular endothelial cell growth factor (VEGF), an important cytokine in the pathogenesis of KS.

OBJECTIVES:

To assess the antitumor effect of bevacizumab 15 mg/kg administered intravenously once every three weeks in patients with human immunodeficiency virus (HIV)-associated Kaposi's sarcoma (KS). Other objectives include assessment of the antitumor effect of bevacizumab 15 mg/kg administered intravenously once every three weeks in patients with classical KS; assessment of the toxicity profile of bevacizumab in HIV-infected and HIV-negative patients with KS; exploration in a preliminary fashion effect of bevacizumab on KS progression free survival; and study of a number of biochemical parameters, including stromal cell-derived factor-1 (SDF-1) expression in KS lesions; human herpes virus-8 (HHV-8) viral load in peripheral blood mononuclear cells; serum vascular endothelial growth factor (VEGF) levels over the course of treatment; and changes in viral interleukin 6 (IL-6) levels over the course of treatment.

ELIGIBILITY:

Key eligibility parameters include HIV-associated or classical Kaposi's sarcoma, age greater than or equal to 18 years, and life expectancy greater than 6 months. Patients with HIV infection must have either KS progression on a regimen of highly active antiretroviral therapy (HAART) for at least one month, or no KS regression while on an optimized regimen of HAART for 4 months or longer.

DESIGN:

Patients will be sequentially enrolled, administered a loading dose of 15 mg/kg bevacizumab intravenously on day 1, and then administered 15 mg/kg bevacizumab intravenously every 3 weeks beginning one week after the loading dose. The drug will be temporarily discontinued for toxicity, intercurrent major surgical procedures, or other factors that would pose a safety concern. Patients will undergo a biopsy of a KS lesion at entry, on cycle 4, day 21, and at the time of a formal response or when the patient stops treatment. Patients will undergo a number of other tests as well, including blood tests and non-invasive imaging studies of KS lesions.

Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients

Phase II Study of Intravenous Recombinant Humanized Anti-Vascular Endothelial Cell Growth Factor Antibody (Bevacizumab) in Classical (HIV-Negative) and in AIDS-Associated Kaposi's Sarcoma

Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.

Here are the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.

Principal Investigator

15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks

Cohort 1 & 2: Pts With HIV-associated and Classic KS

Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma

Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.

Response Rate

All adverse events regardless of attribution, over 202 cycles in 19 patients. Per protocol analysis of adverse events.

Cohort 1 and 2 are reported together.

Number of Participants With Adverse Events

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Risk Factors for Non-HIV-Related Kaposi s Sarcoma	NCT00339326	Kaposi's Sarcom...		18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients	NCT00055237	Kaposi's Sarcom... HIV Infections HIV Seronegativ...	Bevacizumab	18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for ks

Every month we try and update this database with for ks cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ks

Every month we try and update this database with for ks cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ks cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.