Overview
- 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.
- 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.
Description
- 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 and pharmacodynamics (PK/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.
- Objectives
- To obtain and analyze the genomic DNA from patients with cancer, other tumors, and tumor predisposition syndromes on a therapeutic clinical trial.
- To prospectively explore correlations between genetic variants involved in interindividual differences in drug disposition versus pharmacokinetics, pharmacodynamics, response, and toxicity endpoints in patients receiving pharmaceutical agents.
- To mitigate harm due to treatment with ineffective or toxicity-inducing drugs in
patients where gene-drug interactions are established.
- Eligibility
-All individuals enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials.
- Design
-
- Exploratory study with a planned accrual of 1,100 patients
- Genomic DNA will be extracted from blood samples collected from patients (patients with leukemia will have cheek swab samples collected) and genotyped using the Pharmacoscan platform (Thermo).
- In cases where patients carry genetic variants that are 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. This will apply to non-anticancer agents as well given that patients with cancer, other tumors, and tumor predisposition syndromes often receive multiple agents to manage side effects and co-morbidities.
- The association between variants in Pharmacoscan-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.
Eligibility
- INCLUSION CRITERIA:
Patients with cancer, other tumors, or tumor predisposition syndromes currently enrolled in
NIH intramural research program therapeutic trials.
Ability of participant or Legally Authorized Representative (LAR) to understand and be
willing to sign the informed consent document.
Age >= 3 years old
EXCLUSION CRITERIA:
N/A