ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00578630
Recruitment Status : Active, not recruiting
First Posted : December 21, 2007
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
American Cancer Society, Inc.
Montefiore Medical Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Neoplasms Other: buccal swabs and obtaining peripheral blood

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
Estimated Enrollment : 128 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Oncology/Bone Marrow Transplantation Patients
Study Start Date : October 2003
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
peripheral blood and buccal swab


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578630


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
American Cancer Society, Inc.
Montefiore Medical Center
Investigators
Principal Investigator: Paul Meyers, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00578630     History of Changes
Other Study ID Numbers: 03-123
NCI CA 83132
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
pediatric tumors
genetic test development
All Pediatric patients with a histologically proven tumor.