Clinical - Protocol Specific Res. Support

Dana-Farber Cancer Inst, Boston MA

Investigators

Linked publications & trials

Abstract

A core mission of cancer centers is translation of new knowledge into improvements in patient care. The DF/HCC is committed to an active agenda of experimental therapeutics trials, with a primary goal of testing novel agents and approaches for treatment of malignancies. In its laboratory-based studies, potential new therapeutics and approaches are developed that can then be tested by the DF/HCC clinical trials system. These coordinated efforts accelerate the pace from discovery to treatment. Conduct of Early Phase Trials Pilot, Pilot/Phase II, Phase I and Phase l/ll ("Early Phase") clinical trials are the springboard from laboratory advances into clinical study and ultimately to improvements in cancer care, as they are often the first trials that brings a new therapy to patients. In these studies, patients enrolled early in the study are given very low doses of the new treatment, and pharmacokinetic, pharmacodynamic and imaging studies are performed to determine how best to administer the treatment to achieve therapeutic benefit. At the same time, patients must be monitored carefully for side effects and dose-limiting toxicities. Subsequent patients are given higher amounts of the drug until study participants begin to experience unacceptable toxicity. At this point the maximum tolerated dose of the new treatment has been determined and, if appropriate based upon the safety and pharmacokinetic analysis, it can be tested for efficacy against a particular disease type. In other early phase studies new drug regimens are tested in specific patient populations or in new combinations with other drugs, to verify the regimen's safety and to assess, in preliminary fashion, anti-tumor activity. Without critical early phase studies new cancer therapies could not be developed. DF/HCC Institutional Early Phase Trials DF/HCC conducts an extensive portfolio of Pilot/Feasibility, Phase I and Phase l/ll, DF/HCCinvestigator- initiated clinical trials, supported with institutional funds only or with minimal (partial) support from industry. Since the inception of DF/ HCC in 2000, DF/HCC has maintained approximately 60 open early phase studies in any given year (Table 1, below). While the overall number of open early phase studies has not changed over the period from 2000-2003, new patient accrual has increased by 51%, from 352 in 2000 to 532 in 2004, consistent with the expectation that multi-site studies speed patient accrual and therefore accelerate the pace at which exciting and innovative new treatments become approved for clinical use. The number of open protocols and the rate of patient accrual are both anticipated to rise as the BIDMC is more fully integrated into the DF/HCC Clinical Trials System.