Clinical trial · Interventional
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
NCT00436852CI-TRIAL-00039532completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disseminated Neuroblastoma | — | UNRESOLVED | — |
| Recurrent Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-751 | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Measurable disease by CT or MRI scan (ABT-751 chemotherapy)
- description
- 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.
- interventionNames
- Drug: ABT-751
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Evaluable by I-MIBG scintigraphy (ABT-751)
- description
- 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.
- interventionNames
- Drug: ABT-751
- Procedure: quality-of-life assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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-11References
Publications (0)
Data not yet available
No reference posted for this study.