Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Bone Marrow Transplantation Patients - Full Text View

Purpose

The purpose of this study is to develop tests that will allow us to determine who will react differently to the drugs used to treat cancer. We also want to see who will react differently with preparing for a bone marrow transplant.

Condition	Intervention
Neoplasms	Other: buccal swabs and obtaining peripheral blood

MedlinePlus related topics:

Bone Marrow Transplantation Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Oncology/Bone Marrow Transplantation Patients

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To determine if genetic polymorphisms are associated with the presence and extent of chemotherapy related toxicity in pediatric bone marrow transplantation patients and the response and outcome of these patients. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

peripheral blood and buccal swab

Estimated Enrollment:	500
Study Start Date:	October 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 All Pediatric Oncology and Bone Marrow Transplantation Service patients with a histologically proven tumor for whom there is an intent to treat with chemotherapy	Other: buccal swabs and obtaining peripheral blood will be the collection of normal cells and assessments of toxicity following chemotherapy at routine clinic visits.

Detailed Description:

The title of this study is interindividual genetic variability as a determinant of chemotherapy toxicity and response in pediatric oncology/bone marrow transplantation patients. We will collect blood from pediatric oncology/bone marrow transplantation patients who are going to receive chemotherapy in order to assess several defined genetic polymorphisms that may be involved in chemotherapy toxicity and response. The polymorphisms will be assessed on normal mononuclear cells by a combination of techniques. We will determine whether these polymorphisms occur in pediatric oncology/bone marrow transplantation patients and their correlation with different clinical features during and following therapy including toxicity and response. The presence or absence of polymorphisms will be correlated with patient outcome and tumor recurrence.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All Pediatric Oncology and Bone Marrow Transplantation Service patients with a histologically proven tumor for whom there is an intent to treat with chemotherapy

Criteria

Inclusion Criteria:

All Pediatric Oncology and Bone Marrow Transplantation Service patients with a histologically proven tumor for whom there is an intent to treat with chemotherapy are eligible for participation in this study. The patient does not need to be newly diagnosed for enrollment on this protocol.
All patients or their guardians must provide written informed consent. Minors will be required to provide assent.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578630

Contacts


Contact: Paul Meyers, MD		meyersp@mskcc.org

Locations


United States, New York
	Memorial Sloan Kettering Cancer Center	Recruiting
	New York, New York, United States, 10065
	Contact: Paul Meyers, MD meyersp@mskcc.org
	Principal Investigator: Paul Meyers, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

American Cancer Society

Investigators


Principal Investigator:	Paul Meyers, MD	Memorial Sloan-Kettering Cancer Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan Kettering Cancer Center ( Paul Meyers, MD )
Study ID Numbers:	03-123, NCI CA 83132
First Received:	December 19, 2007
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00578630
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

pediatric tumors

genetic test development

All Pediatric patients with a histologically proven tumor.

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) American Cancer Society
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00578630