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Completed

NCT Number: NCT00578630

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

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.

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Key information

Conditions

Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buccal swabs and obtaining peripheral blood

Other

will be the collection of normal cells and assessments of toxicity following chemotherapy at routine clinic visits.

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.
  • Montefiore Medical Center
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2007
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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