ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma
7 other identifiers
interventional
92
2 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2007
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedResults Posted
Study results publicly available
February 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2015
CompletedJuly 17, 2019
July 1, 2019
3.7 years
February 15, 2007
November 19, 2013
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors
Median time to progression observed on ABT-751, along with 95% confidence intervals.
From time to enrollment to death due to any cause, assessed up to 5.1 years
1-year Progression-free Survival
PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum.
From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapy
Secondary Outcomes (6)
Objective Response Rate
Duration of protocol therapy, up to 3 years
Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0
At baseline
Percentage of Participants With Grade 3 or Higher Toxicity
From enrollment until 30 days after the end of protocol therapy
Pharmacokinetics of ABT-751: Cmax
After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.
Pharmacokinetics of ABT-751: Tmax
After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.
- +1 more secondary outcomes
Study Arms (2)
Measurable disease by CT or MRI scan (ABT-751 chemotherapy)
EXPERIMENTALPatients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
Evaluable by I-MIBG scintigraphy (ABT-751)
EXPERIMENTALPatients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
Interventions
Given orally
Ancillary studies
Eligibility Criteria
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)
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (12)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Fox, MD
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2007
First Posted
February 19, 2007
Study Start
January 1, 2007
Primary Completion
September 1, 2010
Study Completion
March 30, 2015
Last Updated
July 17, 2019
Results First Posted
February 28, 2014
Record last verified: 2019-07