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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00436852 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well ABT-751 works in treating children with neuroblastoma that has relapsed or not responded to previous treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: ABT-751 Other: pharmacological study Procedure: quality-of-life assessment |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Recurrent or Refractory Neuroblastoma |
| Estimated Enrollment: | 88 |
| Study Start Date: | January 2007 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, historical control study. Patients are stratified according to disease type (measurable lesions by CT scan or MRI vs evaluable disease [bone marrow or iodine I 123 metaiodobenzylguanidine-positive lesions]).
Patients receive oral ABT-751 once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during course 1 for pharmacokinetic studies.
Quality of life is assessed at baseline and prior to each course of treatment.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed neuroblastoma meeting the following criteria:
Previously irradiated soft tissue or bony lesion must meet ≥ 1 of the following criteria:
Measurable or evaluable disease
Evaluable disease is defined as iodine I 123 metaiodobenzylguanidine (^123I MIBG)-positive lesion at ≥ 1 site
PATIENT CHARACTERISTICS:
Creatinine normal for age and gender as follows:
PRIOR CONCURRENT THERAPY:
More than 4 months since prior allogeneic stem cell transplantation (SCT) (2 months for autologous SCT) and recovered
Contacts and Locations
Show 34 Study Locations| Study Chair: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
| Investigator: | Yael P. Mosse, MD | Children's Hospital of Philadelphia |
More Information
| Responsible Party: | Elizabeth Fox, NCI - Pediatric Oncology Branch |
| ClinicalTrials.gov Identifier: | NCT00436852 History of Changes |
| Other Study ID Numbers: | CDR0000529858, COG-ANBL0621, NCI-07-C-0074, NCI-P6554 |
| Study First Received: | February 15, 2007 |
| Last Updated: | January 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent neuroblastoma disseminated neuroblastoma |
|
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |