Spots Global Cancer Trial Database for N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
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Trial Identification
Brief Title: N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
Official Title: A Phase I Study Of Oral Irinotecan, Temozolomide, Cefixime In Children With Recurrent/Resistant High-Risk Neuroblastoma
Study ID: NCT00093353
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.
Detailed Description: OBJECTIVES: Primary * Determine the maximum tolerated dose of oral irinotecan when administered with fixed-dose temozolomide and cefixime in pediatric patients with recurrent or resistant high-risk neuroblastoma. * Determine the toxic effects of this regimen in these patients. Secondary * Determine the response rate in patients treated with this regimen. * Determine the pharmacokinetics of this regimen in these patients. * Correlate UGT1A1 genotype with the occurrence of dose-limiting diarrhea in patients treated with this regimen. * Correlate BCRP genotype with pharmacokinetic phenotype in patients treated with this regimen. * Correlate p53 status in tumor cells with response in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients receive oral cefixime once daily beginning 5 days before the start of fixed-dose temozolomide and irinotecan and continuing for the duration of the study. Patients also receive oral temozolomide once daily on days 1-5 and oral irinotecan once daily on days 1-5 and 8-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A maximum of 12 patients are treated at the MTD. Patients are followed for toxicity, response, and survival. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.25 years.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Children's Hospital Boston, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital, Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Contact Details
Name: Lars M. Wagner, MD
Affiliation: Children's Hospital Medical Center, Cincinnati
Role: STUDY_CHAIR
Name: Katherine K. Matthay, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
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