Background:
- Some genes may be associated with a greater chance of side effects during cancer
treatment. These genes may also make certain treatments less effective. Researchers want
to collect blood or cheek swab samples from people having cancer treatment to study these
genes.
Objectives:
- To obtain a blood or cheek swab sample to study genetic differences that may affect
cancer treatment.
Eligibility:
- Individuals with cancer who are being treated at the National Cancer Institute.
Design:
- Participants will provide a blood sample for study.
- Participants who have blood-based cancer, such as leukemia, will provide a cheek
swab sample.
- If the blood or cheek swab sample does not have enough genetic material for
analysis, an additional sample may be collected.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01441089.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
Background:
- Genetic polymorphisms in drug-metabolizing enzymes, transporters/receptors might
affect an individual's response to drug therapy.
- Inter-individual differences in efficacy and toxicity of antitumor agents are
especially important given the narrow therapeutic index of these drugs.
- During analysis of investigational agents, inter-individual variation in
pharmacokinetics (PK) and pharmacodynamics (PD) is most often noted. Genetic
variation in genes encoding proteins that regulate or mediate the metabolism and
transport of drugs often account for some of the wide variation seen in PK/PD, and
ultimately the response to, and toxicity from, pharmaceutical agents.
- The administration of probe substrates can be used to determine the phenotype of
enzymes and transporters responsible for drug disposition, providing a useful tool
to better understand the cause of unexpected AEs or toxicities of clinical trial
participants.
Objectives:
-Explore potential associations between genetic variants discovered with Pharmacoscan
involved in inter-individual differences in drug disposition versus the pharmacokinetics,
pharmacodynamics of pharmaceutical agents.
Eligibility:
-Any individual currently enrolled on IRB approved NIH Intramural Research Program (IRP)
therapeutic clinical trials.
Design:
- Exploratory study with a planned accrual of 1,100 participants.
- Genomic DNA extracted from blood samples collected from participants (participants
with leukemia will have cheek swab samples collected) will be analyzed.
- In cases where participants carry genetic variants that related to poor outcome or
significant toxicity on a given drug, clinical recommendations will be provided
where specific instructions are available in the package insert.
- The association between variants in Pharmacoscan-covered genes will be correlated
with PK/PD and clinical outcomes such as response and/or toxicity.
- Genotyping and/or phenotyping probe administration will be used to identify
potential genetic variants with unknown or poorly defined drug interactions,
including genetic variants with unknown metabolic phenotype and drugs with poorly
defined metabolic pathways in the literature.
- The Clinical Pharmacology Program (CPP) will measure the plasma concentration of
enzyme or transporter phenotyping probe substrates (or send the sample out to a
third party if the assay is commercially available) in select participants enrolled
on clinical trials at the CCR.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorWilliam Douglas Figg
