Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity

Summary

Participation Requirements

Description

Background: Pharmacology is the study of pharmaceutical compounds , and encompasses several parameters, including how the body handles the substance (pharmacokinetics, PK), what the substance does to the body at the molecular level (pharmacodynamics), overall efficacy (response), and any adverse eve...

Background: Pharmacology is the study of pharmaceutical compounds , and encompasses several parameters, including how the body handles the substance (pharmacokinetics, PK), what the substance does to the body at the molecular level (pharmacodynamics), overall efficacy (response), and any adverse events or toxicity encountered. The Clinical Pharmacology Program (CPP) within the Center for Cancer Research (CCR) of the National Cancer Institute (NCI) has sensitive, state of the art bioanalytical instrumentation that can accurately and precisely quantitate drug concentrations in plasma. Currently, the CPP can only analyze samples from clinical trials that have explicit instructions (within the Pharmacokinetics section) to do so in the IRB approved protocol. However, clinical trial protocols without a Pharmacokinetics section may still need occasional pharmacokinetic plasma samples drawn and drug concentration measurements performed to help explain unexpected AEs or toxicity or anticipated altered pharmacokinetics. Objectives: - To obtain PK plasma samples from patients being treated with an investigational agent or FDA approved therapy at the NIH who are exhibiting or are anticipated to exhibit unusual response or toxicity that is believed to be due to high drug concentration in order to assess the cause of the toxicity and adverse events.. Eligibility: - Any cancer patients who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible. Design: The CPP will measure the drug plasma concentration (or send the sample out to a third party if the assay is commercially available). The accrual ceiling for this study is 100 patients. The anticipated accrual rate for this protocol is less than 10 patients per year, and based on the accrual ceiling, the duration of accrual and the total study duration is 10 years.

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