0C-10-4: A Phase Ia/Ib Clinical Trial of PRI-724 in Patients with Advanced Solid Tumors
Despite recent progresses in directed chemotherapy, the modern anti-cancer armamentarium only eradicates the majority of drug-sensitive and differentiated tumor cells. Unfortunately, to date no effective therapeutic solution has been developed to treat cancer stem cells. Based on pre-clinical research utilizing CREB-binding proteins/ beta-catenin antagonists, it is hypothesized that such antagonists can target CSCs and thereby offer a novel anti-tumor therapeutic approach.This is a Phase Ia/Ib clinical trial of PRI-724 in patients with advanced solid tumors. It has 2 arms:Phase Ia Accelerated Phase/Dose Escalation and Phase Ib Dose Expansion: PRI-724 MTDThe primary objective of the study is to determine the maximally tolerated dose (MTD) of PRI-724 when administered as a continuous 7-day intravenous infusion to patients with solid tumors. This has been completed in Phase 1a of the study. The Phase 1b will determine the MTD of PRI-274 when combined with mFOLFOX6 in patients with colorectal carcinoma.The secondary objectives are to describe the side effects experienced in both parts of the study, determine the pharmacokinetic profile of PRI-724 and C-82, assess anti-tumor activity, assess the genetic expression of survivin and the effect PRI-724 has on survivin, and assess the affect of C-82 on hair follicle neogenesis and collagen expression. The study also has an exploratory objective to obtain matrix metalloproteinase-7 (MMP7) levels in serum via enzyme-linked immunosorbent assay (ELISA) testing.The starting dose and dose escalation scheme was selected to provide an adequate safety margin based on Good Laboratory Practices (GLP) 28-day continuous iv infusion nonclinical studies. The study consists of accelerated Phase Ia and dose escalation at standard 3+3 phase. Each cycle is defined as 7-day continuous intravenous (iv) infusion followed by a 7-day rest period. At the Maximally Tolerated Dose (MTD), Phase Ib will commence where 18 patients with advanced colorectal cancer who have progressed or whose tumors are no longer responsive to standard therapies will be enrolled.The exact number of patients enrolled will depend on the toxicity observed in each dose escalation cohort and the number of cohorts required to reach MTD.The mRNA level of surviving will be measured in both Phase Ia and Ib. If mRNA level of surviving at day 8 of PRI-724 treatment is decreased 30% or more compared to the level prior to PRI-724 treatment, it suggests that PRI-724 inhibits surviving. In addition to this, assessment will be made of clinical endpoints including tumor response by RECIST and progression-free survival by tumor specimen and circulating tumor cells in every cohort.A typical electronic data capture (EDC) system will be used for data collection.Statistical analysis will be carried out by USC Norris Comprehensive Cancer Center Biostatistics core using SAS Version 9.0 or later.
Lean on me: Research Study for Couples Trying to Stop Smoking
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If you are trying to quit smoking cigarettes, it may be more difficult if your significant other also smokes. Researchers at USC would like to understand whether having a romantic partner who also smokes affects a smoker's attempts to quit. What we learn will help us to develop more effective programs for those who want to quit.</p><p>Relationships are common reasons why people start or continue to smoke. Maybe you grew up around smokers and it seemed natural for you to smoke, too. Maybe your partner smokes and it’s a way that you spend time together. The important people in your life can also be a key to your success in quitting. You might even be surprised by how much help they can be.
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If you participate in the study, we will ask you to visit our USC Health Science Campus lab, complete some questionnaires and interviews about your smoking history and your mood, and complete daily mobile surveys for 4 weeks using your phone. One or both individuals in a relationship can participate, and at least one person has to be a smoker.
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