Overview

This trial is active, not recruiting.

Condition neoplasms
Treatment buccal swabs and obtaining peripheral blood
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date October 2003
End date December 2017
Trial size 128 participants
Trial identifier NCT00578630, 03-123, NCI CA 83132

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
All Pediatric Oncology and Bone Marrow Transplantation Service patients with a histologically proven tumor for whom there is an intent to treat with chemotherapy
buccal swabs and obtaining peripheral blood
will be the collection of normal cells and assessments of toxicity following chemotherapy at routine clinic visits.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
To determine if the presence of genetic polymorphisms are associated with the response and outcome of pediatric oncology/bone marrow transplantation patients.
time frame: 12 months

Eligibility Criteria

Male or female participants of any age.

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:

Additional Information

Official title Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Oncology/Bone Marrow Transplantation Patients
Principal investigator Paul Meyers, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.