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. This is a Phase I protocol to evaluate the safety and tolerability of JVRS-100, a cationic lipid DNA complex (CLDC), for the treatment of patients with relapsed/refractory leukemia. This currently has a dismal prognosis. JVRS-100 consists of complexes of cationic lipid and plasmid DNA without a gene insert (non-coding DNA) which are potent activators of innate and adaptive immunity, induce NK, T and B cell activation, and stimulate the secretion of interferon-?, interferon-?, IL-12 and other cytokines. This is a 2 stage Phase I trial. In stage 1, an accelerated titration schema will be followed with one patient at each dose level. Stage 2 will commence after a dose limiting toxicity (DLT) is observed in stage 1 or after the maximum dose for stage 1 is reached. Stage 2 will follow a modified Fibonacci schema with 3-6 subjects at each dose level until a Recommended Phase 2 Dose (RP2D) is determined. The cohort will then be expanded to a maximum of 12 patients to more fully evaluate the RP2D.
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| Zhang, Lijun; Wang, Ming; Sterling, Nicholas W et al. (2018) Cortical Thinning and Cognitive Impairment in Parkinson's Disease without Dementia. IEEE/ACM Trans Comput Biol Bioinform 15:570-580 |
| Rossi, Alexander; Berger, Kristin; Chen, Honglei et al. (2018) Projection of the prevalence of Parkinson's disease in the coming decades: Revisited. Mov Disord 33:156-159 |
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| Almeida, David M; Lee, Soomi; Walter, Kimberly N et al. (2018) The effects of a workplace intervention on employees' cortisol awakening response. Community Work Fam 21:151-167 |
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| Berryman, Claire E; Fleming, Jennifer A; Kris-Etherton, Penny M (2017) Inclusion of Almonds in a Cholesterol-Lowering Diet Improves Plasma HDL Subspecies and Cholesterol Efflux to Serum in Normal-Weight Individuals with Elevated LDL Cholesterol. J Nutr 147:1517-1523 |
| Calhoun, Susan L; Fernandez-Mendoza, Julio; Vgontzas, Alexandros N et al. (2017) Behavioral Profiles Associated with Objective Sleep Duration in Young Children with Insomnia Symptoms. J Abnorm Child Psychol 45:337-344 |
| Lewis, Mechelle M; Flynn, Michael R; Lee, Eun-Young et al. (2016) Longitudinal T1 relaxation rate (R1) captures changes in short-term Mn exposure in welders. Neurotoxicology 57:39-44 |
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