Spots Global Cancer Trial Database for N2001-03: CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma
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Trial Identification
Brief Title: N2001-03: CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma
Official Title: A Phase I Study Of CEP-701 In Patients With Refractory Neuroblastoma (IND # 67,722)
Study ID: NCT00084422
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of CEP-701 in treating young patients with recurrent or refractory high-risk neuroblastoma.
Detailed Description: OBJECTIVES: Primary * Determine the maximum tolerated dose of CEP-701 in pediatric patients with recurrent or refractory high-risk neuroblastoma. * Determine the dose-limiting toxicity of this drug in these patients. * Determine the pharmacokinetic behavior of this drug in these patients. Secondary * Determine the degree of TrkB tyrosine kinase inhibition activity present in the serum of patients treated with this drug. * Correlate the degree of TrkB tyrosine kinase inhibition activity in these patients with dose level, pharmacokinetics, and antitumor activity data of this drug. * Determine the antitumor activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive oral CEP-701 twice daily\* on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: \*On day 1 of course 1 only, patients receive oral CEP-701 once instead of twice. Cohorts of 3-6 patients receive escalating doses of CEP-701 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. Once the MTD is determined, the dose level is expanded up to 9 patients. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Keywords
Eligibility
Minimum Age: 1 Day
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital Los Angeles, Los Angeles, California, United States
Lucille Salter Packer Children's Hospital, Stanford University, Palo Alto, California, United States
UCSF Helen Diller Family 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
University of Chicago Comer Children's Hospital, Chicago, Illinois, United States
Children's Hospital Boston, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Morgan Stanley Children's Hospital of New York-Presbyterian, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: John M. Maris, MD
Affiliation: Children's Hospital of Philadelphia
Role: PRINCIPAL_INVESTIGATOR
Name: Garrett M. Brodeur, MD
Affiliation: Children's Hospital of Philadelphia
Role: STUDY_CHAIR
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