N2001-03: CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma
- Registration Number
- NCT00084422
- Lead Sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Group lestaurtinib -
- Primary Outcome Measures
Name Time Method To determine dose limiting toxicities (DLTs) of CEP-701 given on this schedule Within first 28 days of therapy. To characterize the pharmacokinetic (PK) behavior of CEP-701 in children with residual or refractory high-risk neuroblastoma. Days 1,5 and 26 of first course only. Participation in PK studies is voluntary and not a requirement for study entry.
To determine the maximum tolerated dose (MTD) of CEP-701 given on a twice daily chronic administration schedule (two days on , two days off) to children with high risk relapsed or residual neuroblastoma. Within 28 days of treatment at each dose level.
- Secondary Outcome Measures
Name Time Method To determine the degree of TrkB tyrosine kinase inhibition activity present in the serum of patients treated with CEP-701, and correlate these findings with dose level, pharmacokinetic and anti-tumor activity data. Days 1,5 and 26 of first course only. To define the antitumor activity of CEP-701, within the confines of a Phase I study. Evaluation at end of courses 1, 2, 4 and then every 4 courses until patient goes off therapy.
Trial Locations
- Locations (12)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
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
University of Chicago Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
🇺🇸Atlanta, Georgia, 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
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States