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Clinical Trial Detail

Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors (SJATRT)

Complete title: PHASE II STUDY OF ALISERTIB AS A SINGLE AGENT IN RECURRENT AND REFRACTORY CENTRAL NERVOUS SYSTEM ATYPICAL TERATOID RHABDOID TUMORS (ATRT) AND EXTRA-CNS MALIGNANT RHABDOID TUMORS (MRT) AND IN COMBINATION THERAPY IN NEWLY DIAGNOSED ATRT (SJATRT)

Research Study Number SC-9010
 
Principal Investigator Sarah Leary
 
Phase II

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number SC-9010
 
Contact Sarah Leary
 
Telephone 206/987-6661
 
E-mail
 

Keywords: Pediatric Cancers, Miscellaneous; Solid Tumors; Teratomas; Neoplasms, Germ Cell and Embryonal; Rhabdoid Tumor; Neoplasms, Complex and Mixed

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