ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment

Completed · Phase 2

Conditions studied: Disseminated Neuroblastoma, Recurrent Neuroblastoma

In brief

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. 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.

Key facts

Study ID

NCT00436852

Run by

Children's Oncology Group

People needed

92

Starts

2007-01-01

Expected to finish

2015-03-30

Last updated by the study team

2019-07-17

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed neuroblastoma meeting the following criteria:
• Refractory or relapsed disease
• No curative treatment option and no additional therapy proven to prolong survival with an acceptable quality of life is available
• Evidence of disease progression (enlargement of existing measurable tumors or the appearance of new tumors) during prior treatment OR biopsy-proven viable neuroblastoma if stable disease but refractory to prior treatment
• Previously irradiated soft tissue or bony lesion must meet ≥ 1 of the following criteria:
• Viable neuroblastoma determined by biopsy ≥ 6 weeks after radiation therapy
• Growth in the lesion determined by CT scan or MRI
• Measurable or evaluable disease
• Measurable disease is defined as ≥ 20 mm in ≥ 1 dimension by MRI, CT scan, or x-ray OR ≥ 10 mm in ≥ 1 dimension by spiral CT scan
• Evaluable disease is defined as iodine I 123 metaiodobenzylguanidine (\^123I MIBG)-positive lesion at ≥ 1 site
• Must not have measurable disease by CT scan or MRI
• No elevated urinary catecholamines and/or bone marrow evidence of tumor, without measurable or evaluable disease by imaging modalities (CT scan, MRI, or \^123I MIBG)
• Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age)
• Life expectancy ≥ 8 weeks
• Hemoglobin ≥ 7.5 g/dL (transfusions allowed)
• Absolute neutrophil count > 250/mm³
• Platelet count > 25,000/mm³ (without platelet transfusion support for ≥ 7 days)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT < 5 times ULN
• Creatinine normal for age and gender as follows: OR creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min
• No greater than 0.4 mg/dL (≤ 5 months)
• No greater than 0.5 mg/dL (6 months-11 months)
• No greater than 0.6 mg/dL (1 year-23 months)
• No greater than 0.8 mg/dL (2 years-5 years)
• No greater than 1.0 mg/dL (6 years-9 years)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.