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

November 16, 2018 updated by: Memorial Sloan Kettering Cancer Center

Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Oncology/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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2003

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 21, 2007

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03-123
  • NCI CA 83132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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