DESCRIPTION OF RESEARCH. Patients are leukapheresed to collect white blood cells. For this process, a needle is inserted into a vein in one arm. Blood is withdrawn by the needle and passed through a device that removes only white blood cells. About one cup of blood circulates in the machine at any time during the procedure. The blood is returned to the patient through a needle in the other arm. Each session will take about 4 hours. Leukapheresis is performed at the beginning of the study and may have to be repeated, depending on the yield of the first leukapheresis and the ex vivo expansion. If necessary, leukapheresis is repeated between 4 -12 weeks after the first one. DC are grown in culture from the collected white cells. rPSMA is added to the cells. The DC plus rPSMA are returned to the patient. It is hoped that these cells will stimulate the body's immune system to kill prostate tumor cells. Patients will receive DC plus rPSMA through an intradermal injection in the upper thigh once every 4 weeks for 12 weeks. The patient is observed during and for 2 hours after each treatment Patients are asked about potential side effects during their next checkup (every month). During the study, patients are physically examined, including blood tests, at various intervals. A bone scan, chest x-ray, and CT of the abdomen and pelvis are performed during week 20 and week 26 of the study. After the study patients are followed as deemed necessary by their treating physician. The physician contacts the patient via a phone call 3 months after their treatment is over to ask about their disease and their quality of life. Before treatment starts, patients have a complete exam including blood and urine tests. A chest x-ray, bone scan, and heart function test (EKG) are done. CT scans of the abdomen and pelvis are performed to measure the tumor. A skin-prick test is done to test for reactions to 3 recall antigens (Candida albicans, Mumps, PPD). For this, small injections are administered in the forearm. The results of the skin-prick tests are checked at 15 minutes and 48 hours after the tests are administered. Treatment of prostate cancer with mature, autologous DC plus rPSMA is authorized by the U.S. Food and Drug Administration for experimental use only. As many as 60 patients will take part in the study. All will be treated as outpatients at a referral cancer center.
DESCRIPTION OF RESEARCH area and plots The research sites used in this case study are situated in the Gunung Lumut Protected Forest in Paser District (see also Chapter 2). Administratively, the Gunung Lumut Protected Forest is located within four sub-districts (namely Batu Sopang, Muara Komam, Long Ikis and Long Kali). Geographically, the position of the area is 1°19’ – 1°49’ South and 116°50’ – 116°20’ East (Anonymous, 2000b). The Government of Indonesia designated the area of Gunung Lumut as Protected Forest due to the forest’s rich ecosystem and the ecological, hydrological and social functions in the region. This protected forest is one of the largest remaining forest blocks left in Southeast Borneo. The total area designated as Gunung Lumut Protected Forest is 35,350 hectares. The Gunung Lumut means ‘Mountain of Xxxx’, and it comprises a mountain range (>500 m altitude) largely covered with lowland Dipterocarp forest (Shorea spp. dominated). This protected forest is located within the Kendilo and Telake watershed areas and is of significant importance for the region as a source of water for at least five rivers, which flow to the populated regions of Long Ikis and Long Kali (Telake River) as well as to the Kendilo River in the Capital City of Tanah Grogot. The research villages of Muluy and Rantau Layung are located within the forest conservation area of the Gunung Lumut Protected Forest. The research area can only be reached by car and the travel time is about seven hours from the provincial capital of Samarinda. According to a government survey (Dinas Perhutanan xxx Konservasi Tanah 1999), the research area is rich in biodiversity. There are a number of species of plants found in the area with a diameter exceeding 10 cm. These are dominated by groups of buni (Aglaia sp), wayan (Aglaia tomen), wild breadfruit (terap or Artocarpus elasticus), nato (Madhuca sericea) and red meranti (Shorea leprosula). In addition to these plants, it is estimated that this area has a potential rattan yield of around 1.2 tons/ha. Other plant products that are useful for the community are honey and jinko, aloeswood, agarwood or oud (gaharu or Aquilaria sp). Figure 3.1. Location of study sites: Muluy and Rantau Layung in Paser District Source: Departement of Forestry, 2002 The different forest types reveal considerable differences in forest structure and species composition. Consequently, they also contain very different forest resources for the local population. Xxxx et al. (2007) note that spec...
DESCRIPTION OF RESEARCH. Isis and Merck will cooperate in the design, synthesis and evaluation of nucleosides and nucleotides as candidate inhibitors of the ( * ) hepatitis C virus. Isis and Merck chemists will collaborate in the design of the modular synthesis and purification of the ( * ) Isis will prepare ( * ) for screening by Merck. Prodrug and other modifications of selected compounds will also be synthesized by Isis to explore structure-activity relationships. It is understood that Merck, in its sole discretion, may also perform the activities to be carried out by Isis. Merck ( * ) will provide support for the modular syntheses *CONFIDENTIAL TREATMENT REQUESTED 11 at Isis by supplying (as agreed by Isis and Merck) pre-weighed samples, with structures, of various starting materials from the Merck proprietary chemical compound collection. All biochemical and biological studies of ( * ) prepared by Isis, which will be directed to the identification and optimization of lead compounds, will be performed by Merck. It is understood that Merck's activities under the Research Program may also, in Merck's discretion, be carried out by Merck's Affiliates and at other Merck sites.
DESCRIPTION OF RESEARCH. The experimental protocol is as follows: Patients for this study will be selected from among patients with non-small cell lung cancer who are not now candidates for radiation therapy or surgery. Patients with local tumors that cannot be removed with surgery or have recurred after radiation can participate. It is not necessary that the patient received chemotherapy (drugs) alone but-chemotherapy may be an alternative treatment. These tumors will be directly injected with the retrovirus. Patients who have known tumors within their airway can also participate. These patients are scheduled to have bronchoscopic exams as part of their evaluation under either local anesthesia or general anesthesia. The surgeon performs an examination using a regular white light source to illuminate the tracheobronchial tree. If a tumor is found that is obstructing a [STAMP] [*] Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. portion of the tracheobronchial tree, that patient will be considered eligible for the study. It must also be possible to reduce the number of tumor cells to a small amount, with removal through the bronchoscope or laser treatment. Costs directly related to this research will not be the responsibility of the patient. These costs will be the responsibility of the sponsor of this research. The tumor must have a specific gene mutation in it. It may be possible to find this mutation in specimens from previous biopsies. However, if these are not available, new biopsies must be performed. If the new biopsy material does not show the mutation, the patient cannot participate in the study. The residual tumor will be injected daily for 5 consecutive days with a retrovirus containing a gene that may be able to correct an abnormality detected in the cancer cells. This treatment may be repeated in three months as long as there is evidence that the tumor is not growing and that the treatment appears safe. The cost of the routine bronchoscopy and biopsies which are part of the work up of patient's condition shall be his/her responsibility. A maximum of 14 patients will be entered in the study. The investigators wish to follow the patient's medical condition for the rest of the patient's life. If the patient should move, the patient should notify Dr. Xxxx'x xxxice.
DESCRIPTION OF RESEARCH. PROJECT (the “Industry Partner”) Collaboration Project Outline (Appendix) Project Title:
DESCRIPTION OF RESEARCH. Specific description of the Research to be carried out by the Institution under the preceding article shall be as set forth in the Proposal of Research Subject (in cases of a newly adopted project) or in the survey sheet for continued project, etc. or equivalent research plan (in cases of continued project).
