This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Subjects with an advanced cancer that produces a non-toxic substance called CEA (carcinoembryonic antigen) that is mostly confined to the peritoneal cavity will be asked to participate in this study. The purpose of this study is to determine the highest dose of gemcitabine that can be given without causing unmanageable side effects when combined with Y-90 Chimeric T84.66 Anti-CEA Antibody injected intraperitoneally through a catheter placed by a surgeon. Treatment on this study is expected to last approximately 18 weeks. After treatment on this study is over, subject's medical condition will be followed on this study for 6 months. Cancer occurring within the peritoneal cavity is difficult to treat. Current treatment involves chemotherapy that is delivered usually intravenously. Intravenous chemotherapy can have difficulty in reaching tumors that are within the peritoneal cavity. Although intravenous chemotherapy can result in anti-tumor effects, these therapies are, in general, not curative. Antibodies are natural protein substances produced by white blood cells to fight infection. They are able to recognize various substances in the body and 'stick' to them. Carcinoembryonic antigen is a non-toxic substance made by some types of cancer that is not found in most normal tissues. When anti-CEA Antibody is 'radiolabeled' with Y-90 to create Y-90 Chimeric T84.66 Anti-CEA Antibody, it is able to take a treatment dose of radiation directly to CEA-producing cancer while avoiding normal tissue. When this radiolabeled antibody is given IP, more antibody can reach cancer in the peritoneal cavity. In a previous study of IP Y-90 Chimeric T84.66 Anti-CEA Antibody, 15 subjects were treated at five different dose levels with only minor side effects. Half of the subjects showed some degree of anti-tumor effects. The highest dose level used in the previous study will be used in the current study. Gemcitabine is a chemotherapy drug that is active against various solid tumors and is also able to make tumors more responsive to radiation treatment. It is hoped that using gemcitabine and Y-90 Chimeric T84.66 Anti-CEA Antibody together will make each treatment more effective. Previous medical experience suggests that subjects can tolerate higher concentrations of gemcitabine when it is given IP. This study will determine the highest dose of IP gemcitabine that can be given with IP Y-90 Chimeric T84.66 Anti-CEA antibody without causing unmanageable side effects to subjects with cancer mostly contained in the peritoneal cavity.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000043-46
Application #
7368167
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
46
Fiscal Year
2006
Total Cost
$13,064
Indirect Cost
Name
University of Southern California
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Davis, J N; Asigbee, F M; Markowitz, A K et al. (2018) Consumption of artificial sweetened beverages associated with adiposity and increasing HbA1c in Hispanic youth. Clin Obes 8:236-243
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Detterich, Jon A (2018) Simple chronic transfusion therapy, a crucial therapeutic option for sickle cell disease, improves but does not normalize blood rheology: What should be our goals for transfusion therapy? Clin Hemorheol Microcirc 68:173-186
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Cooper, Aaron R; Lill, Georgia R; Shaw, Kit et al. (2017) Cytoreductive conditioning intensity predicts clonal diversity in ADA-SCID retroviral gene therapy patients. Blood 129:2624-2635
Arslanian, Silva; El Ghormli, Laure; Bacha, Fida et al. (2017) Adiponectin, Insulin Sensitivity, ?-Cell Function, and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care 40:85-93

Showing the most recent 10 out of 565 publications