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Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors
NCT02114229 · View on ClinicalTrials.gov ↗
Study Summary
This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in the treatment of patients younger than 22 years of age. Patients with recurrent or refractory AT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RT will receive alisertib as part of age- and risk-adapted chemotherapy. Radiation therapy will be given to children ≥12 months of age. Patients with AT/RT and concurrent extra-CNS MRT are eligible. Alisertib will be administered as a single agent on days 1-7 of each 21-day cycle in all recurrent patients enrolled on Stratum A. For the patients on the newly diagnosed strata (B, C or D), alisertib will be administered in sequence with chemotherapy and radiotherapy. This study has 3 primary strata: (A) children with recurrent/progressive AT/RT or extra-CNS MRT, (B) children \< 36 months-old with newly diagnosed AT/RT, (C) children \> 36 months old with newly diagnosed AT/RT. Children with concurrent MRT will be treated according to age and risk stratification schemes outlined for strata B and C and will have additional treatment for local control. Children with synchronous AT/RT will be treated with age and CNS risk-appropriate therapy, and also receive surgery and/or radiation therapy for local control of the non-CNS tumor. PRIMARY OBJECTIVES * To estimate the sustained objective response rate and disease stabilization in pediatric patients with recurrent or progressive AT/RT (atypical teratoid rhabdoid tumor in the CNS) (Stratum A1) treated with alisertib and to determine if the response is sufficient to merit continued investigation of alisertib in this population. * To estimate the sustained objective response rate and disease stabilization in pediatric patients with recurrent or progressive extra-CNS MRT (malignant rhabdoid tumor outside the CNS) (Stratum A2) treated with alisertib and to determine if the response is sufficient to merit continued investigation of alisertib in this population.
Conditions Studied
Interventions
- DRUG cisplatin
- DRUG carboplatin
- DRUG cyclophosphamide
- DRUG alisertib
- DRUG methotrexate
Study Locations (9)
California
- Lucille Packard Children's Hospital at Stanford University Medical Center — Palo Alto
- Rady Children's Hospital — San Diego
Colorado
- Children's Hospital Colorado — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- UF Cancer Center at Orlando Health — Orlando
Georgia
- Children's Healthcare of Atlanta — Atlanta
Minnesota
- Children's Hospital and Clinics of Minnesota — Minneapolis
Tennessee
- St. Jude Children's Research Hospital — Memphis
Texas
- Texas Children's Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2014-05-14 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02114229
The ClinicalTrials.gov registry entry for NCT02114229 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 441 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Malignant Rhabdoid Tumor appearing as the primary indexed condition, and to 5 interventions — of which cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02114229 reports 9 study locations spanning 8 distinct geographic areas — top geographies include California, Colorado, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02114229 about?
NCT02114229 is a clinical study titled "Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors". This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in the treatment of patients younger than 22 years of age. Patients with recurrent or refractory AT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RT will receive alisertib as ...
What is the current status of trial NCT02114229?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2014-05-14. Estimated completion is 2027-09.
What conditions does trial NCT02114229 study?
This clinical trial studies the following conditions: Malignant Rhabdoid Tumor, Atypical Teratoid Rhabdoid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02114229?
The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), cyclophosphamide (DRUG), alisertib (DRUG), methotrexate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02114229?
This trial is sponsored by St. Jude Children's Research Hospital, which has 441 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02114229 being conducted?
This trial has 9 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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