Overview

This trial is active, not recruiting.

Conditions disseminated neuroblastoma, recurrent neuroblastoma
Treatments abt-751, quality-of-life assessment
Phase phase 2
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date January 2007
End date September 2010
Trial size 92 participants
Trial identifier NCT00436852, ANBL0621, CDR0000529858, COG-ANBL0621, NCI-07-C-0074, NCI-2009-00402, NCI-P6554, U10CA098543

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients 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.
abt-751 E7010
Given orally
quality-of-life assessment quality of life assessment
Ancillary studies
(Experimental)
Patients 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.
abt-751 E7010
Given orally
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors
time frame: From time to enrollment to death due to any cause, assessed up to 5.1 years
1-year Progression-free Survival
time frame: 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

Measure
Objective Response Rate
time frame: Duration of protocol therapy
Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0
time frame: 3 weeks
Toxicity as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
time frame: yearsFrom enrollment until 30 days after the end of protocol therapy

Eligibility Criteria

Male or female participants up to 21 years old.

Inclusion Criteria: - 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) - No greater than 1.2 mg/dL (10 years-12 years) - No greater than 1.4 mg/dL (13 years and over [female]) - No greater than 1.5 mg/dL (13 years to 15 years [male]) - No greater than 1.7 mg/dL (16 years and over [male]) - Shortening fraction ≥ 27% by echocardiogram - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-barrier contraception during and for 90 days after completion of study treatment - Seizure disorder allowed if controlled and receiving anticonvulsants - Neurologic toxicity from prior therapy or tumor involvement ≤ grade 2 - No evidence of active graft-vs-host disease - No allergy to sulfa-containing medications - No known HIV positivity - No clinically significant unrelated systemic illness (e.g., serious infection) that would limit study compliance - Concurrent filgrastim (G-CSF) allowed if medically indicated - Recovered from all prior therapy - No prior ABT-751 - More than 2 weeks since prior myelosuppressive chemotherapy - More than 7 days since prior anticancer biologic agents (e.g., retinoids) - More than 4 weeks since prior palliative radiation therapy (small port) or therapeutic ^123I MIBG - More than 6 weeks since prior substantial radiation therapy (> 50% pelvis, craniospinal, or total-body radiation) - More than 4 months since prior allogeneic stem cell transplantation (SCT) (2 months for autologous SCT) and recovered - Infusion of autologous peripheral blood mononuclear cells without high-dose chemotherapy or preparative regimen is not considered SCT - More than 30 days since prior investigational drug therapy - More than 30 days since prior immunotherapy (monoclonal antibody therapy or vaccine therapy) - More than 1 week since prior growth factor treatment - No other concurrent anticancer agents, including chemotherapy, immunomodulating agents, or biologic therapy (retinoids) - No concurrent radiation therapy, including palliative radiation therapy - No concurrent treatment for graft-vs-host disease - No concurrent epoetin alfa, sargramostim (GM-CSF), or interleukin-11

Additional Information

Official title A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma
Principal investigator Elizabeth Fox, MD
Description PRIMARY OBJECTIVES: I. Compare the time to disease progression in children with refractory or relapsed neuroblastoma treated with ABT-751 vs historical controls. SECONDARY OBJECTIVES: I. Determine the objective response rate in patients with measurable disease treatment with this drug. II. Determine whether ABT-751 improves quality of life of these patients. III. Determine the toxicity of ABT-751. IV. Determine the pharmacokinetic profile of ABT-751 in these patients. OUTLINE: 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. After completion of study treatment, patients are followed up for up to 5.1 years.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Children's Oncology Group.