Clinical trial NCT00339664: Analyses of Human Samples Collected in Clinical Trials
Official title: Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myeloid
Neoplasm Metastasis
Leukemia, Lymphoid
Prostate Cancer
Keywords: Pharmacokinetics
Quantify
HPLC
LC/MS
Pharmacodynamics
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 2579
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer@@@

Brief summary: Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood, urine, feces, bile, saliva) for research purposes.

The purpose of this study is to conduct further analyses on these existing samples from clinical trials that are being performed outside of, but in collaboration with, the National Cancer Institute.

Detailed description: Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. These trials are being conducted at outside institutions, in collaboration with the National Cancer Institute (NCI) and the samples will be sent to the NCI for pharmacological analysis, involving determination of parent drug and/or metabolite concentrations and subsequent pharmacokinetics and statistical data analysis. This study aims to further characterize the clinical pharmacokinetic behavior of select cancer therapeutics. Future collaborators will be added via the protocol amendment procedure.

Eligibility criteria: * INCLUSION CRITERIA:

Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer at institutions outside of the intramural NCI are eligible for inclusion, provided that they have consented to pharmacological analysis in the original consent form.

EXCLUSION CRITERIA:

None anticipated at this time.

Primary outcomes:
measure: Drug and/or metabolite concentration
timeFrame: Ongoing
Secondary outcomes:
measure: Pharmacological behavior of agents
timeFrame: Ongoing
Other outcomes:
Locations:
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center &amp; Research Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Lancaster
country: United States
facility: University of Maryland at Amish Research Clinic, Lancaster
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center, University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center at University of Pittsburg Cancer Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: McGuire Veterans Administration Medical Center
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center, Virginia Commonwealth University
state: Virginia
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: National Cancer Institute (NCI)
name: William D Figg, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: