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 States118 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 range1 Year – 21 Years
SexALL
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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 …
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.