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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT00578630
• Date of registration: 19/12/2007
• Primary sponsor: Memorial Sloan-Kettering Cancer Center
• Public title: Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Bone Marrow Transplantation Patients
• Scientific title: Interindividual Genetic Variability as a Determinant of Chemotherapy Toxicity and Response in Pediatric Oncology/Bone Marrow Transplantation Patients
• Date of first enrolment: October 2003
• Target sample size: 400
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00578630
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Paul Meyers, MD

• Name: Paul Meyers, MD

• Name: Paul Meyers, MD
• Affiliation: Memorial Sloan-Kettering Cancer Center

Key inclusion & exclusion 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:

- None



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasms

Intervention(s)

Other: buccal swabs and obtaining peripheral blood

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

03-123

NCI CA 83132

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Cancer Society

Montefiore Medical Center

National Cancer Institute (NCI)