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Sarcoma, Kaposi clinical trials

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NCT ID: NCT00923936 Completed - Sarcoma, Kaposi Clinical Trials

Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma

Start date: April 23, 2009
Phase: Phase 2
Study type: Interventional

Background: - The drug liposomal doxorubicin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Kaposi's sarcoma (KS). A second drug, bevacizumab, is a biologic agent (such as antibodies, interleukins, and vaccines) that stops abnormal blood supply to tumors. Bevacizumab is approved by the FDA, in combination with other drugs, for the treatment of breast cancer, colon cancer, and lung cancer. - Researchers are now studying the combination of liposomal doxorubicin with bevacizumab as a novel approach to the treatment of advanced KS. Researches will be measuring KS tumor responses to this combination to determine whether the drugs might have anti-KS activity. Objectives: - To estimate the overall response rate (ORR) of six cycles of liposomal doxorubicin combined with bevacizumab in patients with advanced KS. - To evaluate the safety of the regimen and to estimate the complete response rate after six cycles, the median number of cycles needed to obtain a partial response, and the 12-month progression-free survival. Eligibility: - Patients 18 years or older with relatively severe acquired immune deficiency syndrome (AIDS)-related KS or patients with KS unrelated to AIDS or human immunodeficiency virus (HIV) infection, whose KS that can be evaluated for potential response to therapy and meet a number of other criteria. - Women who are pregnant or breastfeeding are not eligible. - Other ineligibility criteria include surgery within 4 weeks, chemotherapy within 3 weeks, heart disease, hemoptysis (coughing up blood), or gastrointestinal bleeding. Design: - Researchers will conduct the following tests before the start of the study: - Physical examination and a detailed medical history. - A biopsy. - Blood and urine tests. - Treatment will include two phases, an induction phase and a maintenance phase: - Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles. - Monitoring will include a review of side effects, physical exam (including blood pressure), and blood and urine samples; following the induction phase, the patient will receive a multi gated acquisition scan and electrocardiography (EKG) to record electrical activity in the heart. - Research tests include blood and saliva samples, additional biopsies (optional), and noninvasive imaging. - Treatment is stopped if any of the following occur: completion of 1 year of therapy, progressive KS, patient preference, or unacceptable toxicity. - Post-treatment evaluations include clinic visits every 3 months or as needed up to 2 years, and blood and saliva samples (for research).

NCT ID: NCT00834457 Completed - Clinical trials for AIDS-related Kaposi's Sarcoma

A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe

Start date: June 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Open-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.

NCT ID: NCT00686842 Terminated - Kaposi's Sarcoma Clinical Trials

PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma

Start date: September 2008
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: PTC299 may stop the growth of Kaposi sarcoma by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of PTC299 and to see how well it works in treating patients with HIV-related Kaposi sarcoma.

NCT ID: NCT00587912 Completed - Cancer Clinical Trials

AIDS and Cancer Specimen Bank (ACSB)

Start date: June 1997
Phase: N/A
Study type: Observational

The purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies. The National Cancer Institute has set up a Bank for tissues and biological fluids from HIVpositive and HIV-negative individuals in order to have specimens available for scientists studying malignancies associated with HIV disease.

NCT ID: NCT00581815 Completed - Breast Cancer Clinical Trials

Spectroscopy With Surface Coils and Decoupling

Start date: February 1997
Phase: Phase 1
Study type: Interventional

The purpose of this study is to obtain chemical information from part of your body without a biopsy. This is done using a technique called magnetic resonance spectroscopy (MRS) which is similar to magnetic resonance imaging (MRI) except that signals are detected from the chemicals (spectroscopy) naturally present in your body using radio waves. To receive this information from your body, small loops of wire (surface coils), placed near the tissue of interest, may be used to more effectively detect signals that come from the chemicals in your body. The investigators may use a second radio channel simultaneously, which will allow us to obtain greater chemical information (decoupling). The results may also help us to understand how this study can be used to help other patients with your condition.

NCT ID: NCT00540566 Completed - Burns Clinical Trials

Optical Biopsy of Human Skin in Conjunction With Laser Treatment

Start date: June 1999
Phase:
Study type: Observational

This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

NCT ID: NCT00521092 Withdrawn - Clinical trials for AIDS-related Kaposi Sarcoma

Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying the side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.

NCT ID: NCT00450320 Completed - Sarcoma Clinical Trials

Sirolimus in Treating Patients With HIV-Related Kaposi's Sarcoma

Start date: October 2007
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sirolimus also may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This pilot study is studying sirolimus in treating patients with HIV-related Kaposi's sarcoma.

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: NCT00427414 Terminated - Sarcoma Clinical Trials

Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma

Start date: September 2008
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating patients with HIV-related Kaposi's sarcoma.