Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia (NCT01154816) | Clinical Trial Compass
CompletedPhase 2
Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia
United States, Canada118 participantsStarted 2011-02
Plain-language summary
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range
1 Year – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have had histologic verification of malignancy at original diagnosis or at relapse, to include any of the following malignancies (no other histology is eligible):
* Neuroblastoma- measurable
* Neuroblastoma- MIBG evaluable
* Rhabdomyosarcoma
* Osteosarcoma
* Ewing sarcoma/Peripheral PNET
* Non-RMS soft tissue sarcoma
* Hepatoblastoma
* Malignant germ cell tumor
* Wilms tumor
* Acute lymphoblastic leukemia
* Acute myelogenous leukemia
* Rhabdoid malignancy
* Disease status for solid tumor patients:
* Patients must have radiographically measurable disease (with the exception of neuroblastoma)
* Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 20 mm in at least one dimension; for spiral CT, measurable disease is defined as a minimum diameter of 10 mm in at least one dimension
* Note: The following do not qualify as measurable disease:
* Malignant fluid collections (e.g., ascites, pleural effusions)
* Bone marrow infiltration
* Lesions detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography \[PET\] scans)
* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
* Previously irradiated lesions that have not demonstrated clear progression post radiation
* Patients with neuroblastoma who do not …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Overall Response
Timeframe: From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.