St. Jude Children's Research Hospital
The purpose of this study is to test whether giving treatment before surgery helps babies who are newly diagnosed with Infant-Type Hemispheric Glioma (IHG) have safer and better surgery results.
Primary Objective * To estimate the complete tumor response rate (CTR) associated with molecularly directed neoadjuvant treatment (entrectinib for NTRK1/2/3 and ROS1, alectinib for ALK, and chemotherapy for tumors with other fusions and no fusions). (Strata A, B, and C) * To estimate the safe surgical resection rate associated with molecular-directed neo-adjuvant treatment entrectinib for NTRK1/2/3 and ROS1, alectinib for ALK, and chemotherapy for tumors with other fusions and no fusions. (Strata A, B, and C) Secondary Objectives * To estimate the stratum-specific and study-wide event-free…
Inclusion Criteria: Screening * Patient with presumptive or suspected (new) diagnosis of Infant-Type Hemispheric Glioma (IHG) * Patient age at diagnosis is from birth to ≤ 60 months * Patient has MRI/CT scan imaging of a supra-tentorial, hemispheric tumor avail-able for review before screening consent. * Patient is willing to undergo a biopsy procedure to confirm tissue diagnosis. * Adequate tumor tissue for central review of pathology, at the St. Jude Children's Research Hospital, DNA methylation array analysis, and NGS testing should be provided, if available from previous surgery, but is n…
By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28
By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28
Primary surgery (Strata A, B, and C) post Neoadjuvant therapy with a goal of attaining gross total (GTR) or near total resection (NTR) of the tumor.
IV (intravenous) day 1
IV (intravenous) days 1 and 2
IV (intravenous) day 2
Subcutaneous (under the skin) or IV (intravenous) day 3
Subcutaneous (under the skin) day 3
Primary surgery (Strata A, B, and C) post Neoadjuvant therapy with a goal of attaining gross total (GTR) or near total resection (NTR) of the tumor.
Arctuva estimate
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