For more than 40 years, the National Cancer Institute (NCI) has supported an infrastructure program to conduct clinical trials across the US. To enhance, facilitate, and expedite the process of early-phase drug development, the NCI implemented a comprehensive plan transforming the NCI-sponsored early-phase clinical trials program from a series of separate institutions and efforts to a new, consolidated, integrated program, referred to as the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). The UPMC Hillman Cancer Center (formerly the University of Pittsburgh Cancer Institute, hereafter referred to as ?HCC?) has been an NCI-designated comprehensive cancer center since 1990, and has been involved in the NCI Early Drug Development Program since 1999. Our group was one of 12 academic centers to be selected as an ETCTN Lead Academic Organization (LAO) for the phase 1 component, and subsequently selected as one of 10 academic centers to integrate phase 2 clinical trial efforts, with responsibility for developing, leading, and accruing to ETCTN clinical trials for adult cancer patients. We now propose to be a member of the NCI ETCTN as the Pittsburgh Cancer Consortium (PCC) Lead Academic Organization in a consortium with the University of Florida Health Cancer Center and the Albert Einstein Cancer Center. The goal of the PCC is to create a unified, integrated clinical trials network that will allow for more seamless advancement and progress of novel experimental agents and/or combinations through early stages of drug development. The eventual goal of our program is to greatly facilitate and accelerate the delivery of new cancer therapies to the citizens of Pennsylvania, North-Central Florida, Bronx, NY, and their respective catchment areas.

Public Health Relevance

The overarching goal of the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) is to enhance and facilitate the efficient and comprehensive conduct of early-phase clinical trials of NCI Investigation New Drug (IND) agents. The UPMC Hillman Cancer Center (HCC) proposes to be a member of the NCI ETCTN as the Pittsburgh Cancer Consortium (PCC) Lead Academic Organization in a consortium with the University of Florida Health Cancer Center (UFHCC) and the Albert Einstein Cancer Center (AECC). The mission of the PCC is to create a unified, integrated clinical trials network that will allow for more seamless advancement and progress of novel experimental agents and/or combinations through early stages of drug development. The long-term goal is to guide the development and conduct of early-phase clinical trials that may have the potential to change the standard of cancer care in the U.S. and worldwide.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1CA186690-06
Application #
9933233
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Ivy, S Percy
Project Start
2014-03-25
Project End
2023-02-28
Budget Start
2020-05-07
Budget End
2023-02-28
Support Year
6
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15260
Singh, Renu; Mehrotra, Shailly; Gopalakrishnan, Mathangi et al. (2018) Population pharmacokinetics and exposure-response assessment of veliparib co-administered with temozolomide in patients with myeloid leukemias. Cancer Chemother Pharmacol :
Benoist, Guillemette E; van der Meulen, Eric; van Oort, Inge M et al. (2018) Development and Validation of a Bioanalytical Method to Quantitate Enzalutamide and its Active Metabolite N-Desmethylenzalutamide in Human Plasma: Application to Clinical Management of Patients With Metastatic Castration-Resistant Prostate Cancer. Ther Drug Monit 40:222-229
Vendetti, Frank P; Karukonda, Pooja; Clump, David A et al. (2018) ATR kinase inhibitor AZD6738 potentiates CD8+ T cell-dependent antitumor activity following radiation. J Clin Invest 128:3926-3940
Bakkenist, Christopher J; Lee, James J; Schmitz, John C (2018) ATM Is Required for the Repair of Oxaliplatin-Induced DNA Damage in Colorectal Cancer. Clin Colorectal Cancer 17:255-257
Appleman, Leonard J; Maranchie, Jodi K (2018) Systemic therapy following metastasectomy for renal cell carcinoma: Using insights from other clinical settings to address unanswered questions. Urol Oncol 36:17-22
Beumer, Jan H; Chu, Edward; Allegra, Carmen et al. (2018) Therapeutic Drug Monitoring in Oncology: International Association of Therapeutic Drug Monitoring and Clinical Toxicology Recommendations for 5-Fluorouracil Therapy. Clin Pharmacol Ther :
Beumer, Jan H; Inker, Lesley A; Levey, Andrew S (2018) Improving Carboplatin Dosing Based on EstimatedĀ GFR. Am J Kidney Dis 71:163-165
Soumerai, Jacob D; Zelenetz, Andrew D; Moskowitz, Craig H et al. (2017) The PARP Inhibitor Veliparib Can Be Safely Added to Bendamustine and Rituximab and Has Preliminary Evidence of Activity in B-Cell Lymphoma. Clin Cancer Res 23:4119-4126
Niu, Jing; Scheuerell, Christie; Mehrotra, Shailly et al. (2017) Parent-Metabolite Pharmacokinetic Modeling and Pharmacodynamics of Veliparib (ABT-888), a PARP Inhibitor, in Patients With BRCA 1/2-Mutated Cancer or PARP-Sensitive Tumor Types. J Clin Pharmacol 57:977-987
Vendetti, Frank P; Leibowitz, Brian J; Barnes, Jennifer et al. (2017) Pharmacologic ATM but not ATR kinase inhibition abrogates p21-dependent G1 arrest and promotes gastrointestinal syndrome after total body irradiation. Sci Rep 7:41892

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