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

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• Neuroblastoma 625

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's enrollment of 92 is above the median of 32 across 475 interventional studies indexed under Neuroblastoma.

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Measurable disease by CT or MRI scan (ABT-751 chemotherapy)

  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.

  Drug: ABT-751 · Procedure: quality-of-life assessment

• Experimental
  Evaluable by I-MIBG scintigraphy (ABT-751)

  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.

  Drug: ABT-751 · Procedure: quality-of-life assessment

Interventions

• DrugABT-751

  Given orally

  Also known as: E7010

• Procedurequality-of-life assessment

  Ancillary studies

  Also known as: quality of life assessment

Primary outcomes

1. 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.

   Time frame: From time to enrollment to death due to any cause, assessed up to 5.1 years

2. 1-year Progression-free Survival

   PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum.

   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

1. Objective Response Rate

   The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the percentage. Responders were defined as patients who achieved a best overall response of complete response (CR) or partial response (PR) at any time on the study including patients who achieved ≥PR and later had progressive disease or relapse. Response in patients with measurable disease will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or by Curie criteria for measuring response by MIBG scans in patients with evaluable disease by 123I-MIBG scan. Per RECIST: CR= Disappearance of all target lesions; PR= at least 30% decrease in the sum of the longest diameter of target lesions. Per Curie criteria: CR= complete resolution of all MIBG positive lesions; PR= resolution of at least one MIBG positive lesion with persistence of other MIBG positive lesions.

   Time frame: Duration of protocol therapy, up to 3 years

2. Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0

   The QOL score will be reverse linearly transformed to a 0-100 percentage point scale (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating better health-related quality of life, and the average of all 23 items will be calculated as the composite score.

   Time frame: At baseline

3. Percentage of Participants With Grade 3 or Higher Toxicity

   Percentage of patients with at least one Grade 3 or higher toxicity, as assessed by Common Terminology Criteria for Adverse Events version 3.0, will be tabulated.

   Time frame: From enrollment until 30 days after the end of protocol therapy

4. Pharmacokinetics of ABT-751: Cmax

   Values of the maximum observed concentration (Cmax) will be determined for the first dose.Descriptive statistics for these variables will be provided.

   Time frame: After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.

5. Pharmacokinetics of ABT-751: Tmax

   Values of the time to maximum observed concentration (Tmax) will be determined for the first dose.Descriptive statistics for these variables will be provided.

   Time frame: After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.

6. Pharmacokinetics of ABT-751: AUC

   Values of the area under concentration time curve \[AUC(0-∞)\] will be determined for the first dose. Descriptive statistics for these variables will be provided.

   Time frame: After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.

Baseline characteristics