Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/22/2018 |
| Start Date: | September 7, 2004 |
Retrospective Analysis of Drug Disposition and Response-related Genotypes in Cancer Patients and Correlation With Pharmacokinetics and Pharmacodynamics Data
This study is a retrospective one, exploring the hypothesis that a person's genotypic makeup
may be associated with a clinical response or toxic effect to a drug. Genetic polymorphisms,
that is, states of being able to assume different forms, that are in drug-metabolizing
enzymes, transporters, and receptors may affect a patient's response to drug therapy. To
date, there have been limited studies looking at a drug-metabolizing genotype (genetic
makeup) or phenotype (result of the genotype's interaction with the environment). However, it
is often wondered if the variations in a drug's action, that is, pharmacokinetic effect, come
from the genotype phenotype relationship.
Participants who entered previous clinical trials at the National Cancer Institute, as
approved by the Central Institutional Review Board, may be eligible for this study. Studies
for which pharmacokinetic analyses were or are being performed will be the source of the
patient population.
Genotyping experiments will be performed through genomic DNA isolated from stored frozen
serum. The genotyping results will be compared with pharmacokinetic data and clinical
outcomes. Clinical data will consist of what is obtained during the course of the principal
pharmacokinetic study. The results of the retrospective analyses will provide no direct
benefit to the participants.
may be associated with a clinical response or toxic effect to a drug. Genetic polymorphisms,
that is, states of being able to assume different forms, that are in drug-metabolizing
enzymes, transporters, and receptors may affect a patient's response to drug therapy. To
date, there have been limited studies looking at a drug-metabolizing genotype (genetic
makeup) or phenotype (result of the genotype's interaction with the environment). However, it
is often wondered if the variations in a drug's action, that is, pharmacokinetic effect, come
from the genotype phenotype relationship.
Participants who entered previous clinical trials at the National Cancer Institute, as
approved by the Central Institutional Review Board, may be eligible for this study. Studies
for which pharmacokinetic analyses were or are being performed will be the source of the
patient population.
Genotyping experiments will be performed through genomic DNA isolated from stored frozen
serum. The genotyping results will be compared with pharmacokinetic data and clinical
outcomes. Clinical data will consist of what is obtained during the course of the principal
pharmacokinetic study. The results of the retrospective analyses will provide no direct
benefit to the participants.
Background
Genetic polymorphisms in drug-metabolizing enzymes, transporterss/receptors, and
transcription factors might affect an individual s response to drug therapy.
Inter-individual differences in efficacy and toxicity of cancer chemotherapy are especially
important given the narrow therapeutic index of these drugs.
During analysis of investigational agents, inter-individual variances in pharmacokinetics and
pharmacodynamics are often noted. It is often wondered if these variances might in part be
explained by genetic differences in drug metabolizing enzymes, transporters, or other
criticial regulators of gene expression.
Objectives
To better understand the genotype-phenotype relationship, additional analysis correlating
pharmacokinetic data with relevant genotyping.
Eligibility
All individuals previously enrolled on IRB approved clinical trials at the National Cancer
Institute.
Design
In these retrospective studies, the association between an individual s pharmacokinetic
profile and the genetic variation in their drug metabolizing enzymes and other critical
regulators of gene expression will be investigated.
The hypothesis that an individual s genotypic constitution may be associated with clinical
response and/or toxicity will be explored.
Genetic polymorphisms in drug-metabolizing enzymes, transporterss/receptors, and
transcription factors might affect an individual s response to drug therapy.
Inter-individual differences in efficacy and toxicity of cancer chemotherapy are especially
important given the narrow therapeutic index of these drugs.
During analysis of investigational agents, inter-individual variances in pharmacokinetics and
pharmacodynamics are often noted. It is often wondered if these variances might in part be
explained by genetic differences in drug metabolizing enzymes, transporters, or other
criticial regulators of gene expression.
Objectives
To better understand the genotype-phenotype relationship, additional analysis correlating
pharmacokinetic data with relevant genotyping.
Eligibility
All individuals previously enrolled on IRB approved clinical trials at the National Cancer
Institute.
Design
In these retrospective studies, the association between an individual s pharmacokinetic
profile and the genetic variation in their drug metabolizing enzymes and other critical
regulators of gene expression will be investigated.
The hypothesis that an individual s genotypic constitution may be associated with clinical
response and/or toxicity will be explored.
- INCLUSION CRITERIA:
In this retrospective study, any cancer patients entered on IRB approved clinical trials at
the National Cancer Institute are eligible. Studies for which pharmacokinetic analyses
were/are being performed will be the source of the patient population. At this time
enrollment will be limited to patients with pharmacokinetic samples obtained during
treatment on protocol 00-C-0033, 00-C-0080, 01-C-0049, 01-C-0124, 01-C-0215, 02-C-0061,
02-C-0083, 02-C-0130, 02-C-0149, 02-C-0215, 02-C-0218, 02-C-0229, 03-C-0030, 03-C-0157,
03-C-0176, 03-C-0284, 04-C-0132, 04-C-0257, 04-C-0262, 04-C-0273, 04-C-0280, 05-C-0022,
05-C-0049, 05-C-0167, 05-C-0186, 06-C-0083, 06-C-0088, 06-C-0164, 06-C-0221, 07-C-0047,
07-C-0059, 07-C-0106, 07-C-0107, 08-C-0030, 08-C-0074, 94-C-0169, 95-C-0015, 97-C-0135,
97-C-0171, and 98-C-0015.
EXCLUSION CRITERIA:
A patient will be excluded if there is an insufficient quantity of sample available to
perform the genotyping procedure. This is not anticipated to be of significance for this
study since the methodology does not require a large serum sample.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
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