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

NCT ID: NCT00578630

Last Updated: 2018-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-14

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

buccal swabs and obtaining peripheral blood

Intervention Type OTHER

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

Interventions

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buccal swabs and obtaining peripheral blood

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Meyers, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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NCI CA 83132

Identifier Type: -

Identifier Source: secondary_id

03-123

Identifier Type: -

Identifier Source: org_study_id

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