View clinical trials related to Sarcoma, Kaposi.
Filter by:To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.
To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.
To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.
To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.
To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.
This protocol presents the rationale, 25-year historical review, and methods for multidisciplinary, low-risk studies of individuals referred to the NCI Viral Epidemiology Branch (VEB). Referrals are generally for unusual types of cancer or related conditions, known, or suspected to be related to viruses. Kaposi's sarcoma in two homosexual men evaluated in 1981 is a classic example. These referral cases provide the basis for pilot studies that generate hypotheses, the development of protocols for formal investigations of promising leads, and help to set priorities for VEB. A VEB investigator who is a Staff Member at the NIH Clinical Center, interviews each subject, performs a physical examination, draws a blood sample, and, when appropriate for the disease or virus under study, obtains other clinically indicated biological specimens, such as urine, sputum, saliva, tears, semen, Pap smear, or cervical, anal, oral, or nasal swabs. On occasion, other relatively non-invasive studies may be indicated. Skin testing with conventional, licensed antigens for assessment of cellular immunity may be performed, and skin lesions may be biopsied or excised. Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated for other reasons. Otherwise no surgery is performed, and no therapy is administered. Clinical referral to other components of NCI, NIH, or the private sector are made as needed. The biological specimens are frozen or otherwise preserved to be batch tested in current assays or future assays that will be developed. Such laboratory testing is performed either at VEB's own support laboratory, or collaboratively in other NCI, NIH, or extramural laboratories that have the needed expertise for the disease or virus under study. Occasionally, repeated or more long-term evaluation is required. More often, a single evaluation in the NIH outpatient clinic, or either at a collaborating physician's office or other suitable site in the field, is sufficient. The VEB investigator provides counseling relevant to the virus or disease under study, and about the interim study results. He or she makes appropriate referral if needed (e.g., to the Genetic Epidemiology Branch for genetic counseling). Clinically relevant results and the VEB investigator's interpretation of these results, are provided in writing to the subject's primary caregiver. Confidentially of the information that is obtained is carefully protected. The results of the study are summarized for publication in the peer review literature.
This study will test the safety and effectiveness of genetically altered T lymphocytes (white blood cells of the immune system) in reducing viral load in patients infected with the human immunodeficiency virus (HIV). The lymphocytes will have two genes inserted into them; a laboratory-manufactured anti-HIV gene designed to inhibit HIV reproduction (either the RevTD or Rev-TD-antiTAR gene), and a "marker" gene that will show whether or not the inserted genes have gotten into the cells. Identical twin pairs 18 years of age and older- one of whom is HIV-positive (infected with the human immunodeficiency virus) and the other HIV-negative (not infected) may be eligible for this study. All participants will have a complete medical history and physical examination, blood tests and a tetanus booster shot, if indicated. The non HIV-infected twin will then undergo lymphapheresis to collect lymphocytes. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The lymphocytes are then removed, and the red cells and plasma are returned to the donor, either through the same needle or through a second needle placed in the other arm. The donor cells are grown in the laboratory for a few days, and then the new genes are inserted into them. The genetically altered cells are grown in the laboratory for several days until their numbers increase approximately a thousand-fold. They are then infused intravenously (through a vein) into the infected twin. These procedures-lymphapheresis, gene modification and infusion-will be repeated at approximately 2-month intervals up to four times. Each lymphocyte infusion takes about 60 minutes. The patient's vital signs (temperature, pulse, blood pressure and breathing) are monitored frequently during the infusion and hourly for 4 hours after the infusion. Blood samples are taken the day of the infusion, 3 days later, and then weekly to monitor the gene-modified cells, immune status, viral activity, and other factors. These tests may be done less often as the study progresses and more is learned about the safety of the infusions. The infusions are done on an outpatient basis unless side effects require that they be done in the hospital with post-infusion monitoring for at least 24 hours. Patients will be followed for long-term effects of treatment monthly for the first 3 months, once a month for the next 9 months and yearly from then on. This study will contribute information about the use and side effects of gene therapy in HIV infection that may lead to new treatment strategies. A potential direct benefit to HIV-infected individuals participating in this study is reduced viral load; in laboratory studies, the RevTD and Rev-TD-antiTAR genes have inhibited HIV spread in the test tube. However, this is an early phase of study, and the likelihood of receiving this benefit is unknown.
We propose to test, by DNA linkage analysis of family pedigree members, the following interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and 3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on a genetic basis and/or influenced by candidate behavioral loci. The subjects for these studies will be self-identified male and female homosexual probands and their relatives from families in which there are at least two individuals with homosexual orientation. All subjects will be adults, and will be referred through NIH physicians, private practitioners, and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination, endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples will be analyzed for a series of genetic markers that span the human genome and for candidate loci chosen for function.