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

NCT00578630 | Completed

• 2 other identifiers: 03-123NCI CA 83132
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

pediatric tumors; genetic test development; All Pediatric patients with a histologically proven tumor.

Outcome Measures

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.

  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.

  12 months

Study Arms (1)

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

Interventions

buccal swabs and obtaining peripheral blood OTHER

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

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• American Cancer Society, Inc.: collaborator
• Montefiore Medical Center: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood and buccal swab

MeSH Terms

Conditions

Neoplasms

Study Officials

• Paul Meyers, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: October 14, 2003
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

US (1)