Laboratory Study of Tissue Samples Collected From Patients With Cancer Treated on a Clinical Trial Outside of the National Cancer Institute Center for Cancer Research

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), December 2008

First Received: May 9, 2009 No Changes Posted

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00898196

Purpose

RATIONALE: Measuring levels of anticancer drugs in samples of tissue from patients with cancer in the laboratory may help doctors plan treatment and may help the study of cancer in the future.

PURPOSE: This laboratory study is measuring levels of anticancer drugs in tissue samples collected from patients with cancer treated on a clinical trial outside of the National Cancer Institute Center for Cancer Research.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Other: pharmacological study

Study Type:	Observational
Official Title:	Pharmacological Analysis Of Human Samples Collected In Clinical Trials Performed Outside Of The Intramural National Cancer Institute

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Drug and/or metabolite concentrations in various samples [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical pharmacological behavior of cancer therapeutics being studied in clinical trials [ Designated as safety issue: No ]

Study Start Date:

March 2005

Detailed Description:

OBJECTIVES:

Primary

Quantitate drug and/or metabolite concentrations in various samples collected from patients with cancer treated on clinical trials outside of the National Cancer Institute Center for Cancer Research.

Secondary

Characterize the clinical pharmacological behavior of cancer therapeutics being studied in these clinical trials.

OUTLINE: Various samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) collected during the original clinical trial are received for pharmacological analysis, determination of the parent drug and/or metabolite concentrations, and subsequent pharmacokinetics and statistical data analysis.

PROJECTED ACCRUAL: Not specified.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Enrolled on an approved cancer therapeutics clinical trial at an institution outside of the National Cancer Institute Center for Cancer Research
Consented to pharmacological analysis in the original clinical trial consent

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898196

Locations

United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937
United States, Minnesota
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Netherlands
Leiden University Medical Center	Recruiting
Leiden, Netherlands, 2300 RC
Contact: Hans Gelderblom, MD, PhD 31-71-526-3486

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

William D. Figg, PharmD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000347464, NCI-03-C-0242, NCI-03-C-N242
Study First Received:	May 9, 2009
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00898196 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 11, 2009