Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

Completed · Phase 2

Conditions studied: Hepatoblastoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Kidney Neoplasm, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma

In brief

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.

Key facts

Study ID: NCT01154816
Run by: Children's Oncology Group
People needed: 118
Starts: 2011-02-01
Expected to finish: 2019-06-30
Last updated by the study team: 2020-05-13

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 have measurable disease but have MIBG+ evaluable disease are eligible
Disease status for leukemia patients:
Patients with leukemia must be recurrent or refractory to at least two prior induction or treatment regimens, in addition to the following criteria:

You may not qualify if…

Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy; breastfeeding women are excluded
Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)
Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible
Use of daily benzodiazepine therapy excludes a patient from being eligible because of the potential benzodiazepine-like effects of MLN8237
Patients who are currently receiving digoxin, cyclosporine, tacrolimus, or sirolimus are not eligible
Patients who are unable to swallow tablets are not eligible
Patients who have an uncontrolled infection are not eligible
Leukemia patients with CNS disease are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Where it is running

University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Southern California Permanente Medical Group — Downey, California, United States
Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
Children's Hospital Central California — Madera, California, United States
Children's Hospital of Orange County — Orange, California, United States
Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
Rady Children's Hospital - San Diego — San Diego, California, United States
UCSF Medical Center-Parnassus — San Francisco, California, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Yale University — New Haven, Connecticut, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Lee Memorial Health System — Fort Myers, Florida, United States
Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
Florida Hospital Orlando — Orlando, Florida, United States
Nemours Children's Clinic - Orlando — Orlando, Florida, United States
UF Cancer Center at Orlando Health — Orlando, Florida, United States
Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
All Children's Hospital — St. Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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