Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia
Recruiting in Palo Alto (17 mi)
+104 other locations
YM
Overseen byYael Mosse
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Children's Oncology Group
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Research Team
YM
Yael Mosse
Principal Investigator
Children's Oncology Group
Eligibility Criteria
Inclusion Criteria
Rhabdomyosarcoma
Osteosarcoma
Ewing sarcoma/Peripheral PNET
See 7 more
Treatment Details
Interventions
- Alisertib (Aurora Kinase Inhibitor)
Participant Groups
12Treatment groups
Experimental Treatment
Group I: Arm XII (rhabdoid malignancy)Experimental Treatment3 Interventions
Patients with rhabdoid malignancy receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm XI (acute myelogenous leukemia)Experimental Treatment3 Interventions
Patients acute myelogenous leukemia receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group III: Arm X (acute lymphoblastic leukemia)Experimental Treatment3 Interventions
Patients with acute lymphoblastic leukemia receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group IV: Arm VIII (malignant germ cell tumor)Experimental Treatment3 Interventions
Patients with malignant germ cell tumor receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group V: Arm VII (hepatoblastoma)Experimental Treatment3 Interventions
Patients hepatoblastoma receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group VI: Arm VI (non-RMS soft tissue sarcoma)Experimental Treatment3 Interventions
Patients with non-RMS soft tissue sarcoma receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group VII: Arm V (Ewing sarcoma/peripheral PNET)Experimental Treatment3 Interventions
Patients with Ewing sarcoma/peripheral PNET receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group VIII: Arm IX (Wilms tumor)Experimental Treatment3 Interventions
Patients with Wilms tumor receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group IX: Arm IV (osteosarcoma)Experimental Treatment3 Interventions
Patients with osteosarcoma receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group X: Arm III (rhabdomyosarcoma)Experimental Treatment3 Interventions
Patients with rhabdomyosarcoma receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group XI: Arm II (Neuroblastoma- MIBG evaluable)Experimental Treatment3 Interventions
Patients MIBG evaluable neuroblastoma receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Group XII: Arm I (neuroblastoma- measurable)Experimental Treatment3 Interventions
Patients with measurable neuroblastoma receive alisertib PO QD on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
Trials
467
Recruited
241,000+
Dr. Doug Hawkins
Children's Oncology Group
Chief Executive Officer since 2020
MD from University of Washington School of Medicine
Dr. Leo Mascarenhas
Children's Oncology Group
Chief Medical Officer since 2024
MD, MS from Cedars-Sinai Guerin Children’s
National Cancer Institute (NCI)
Collaborator
Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School