OncoMatch/Clinical Trials/NCT06942039

Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation

Is NCT06942039 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments for cns embryonal tumor.

Early Phase 1RecruitingC17 CouncilNCT06942039Data as of May 2026

Treatment: Cytarabine IT · hydrocortisone · Cisplatin · Vincristine · Etoposide · Cyclophosphamide · Mesna · Filgrastim · carboplatin · Thiotepa · Topotecan IT · Tamoxifen · ISOtretinoin · Celecoxib · etoposide phosphate · Temozolomide — Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Neuroblastoma

Biomarker criteria

Required: SMARCB1 INI-1 intact

CNS embryonal tumor with rhabdoid features (INI-1 intact)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Min 0 prior lines

Cannot have received: radiotherapy

Exception: corticosteroids allowed

Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids

Cannot have received: chemotherapy

Exception: corticosteroids allowed

Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids

Lab requirements

Blood counts

ANC > 1000/μL; Platelet Count > 100,000/μL (without transfusion for 3 days); Hemoglobin > 8 gm/dL (may have received RBC transfusions)

Kidney function

Creatinine clearance (12-24-hour urine collection) or radioisotope GFR ≥ 60 ml/min/1.73m2

Liver function

Total bilirubin ≤ 1.5X ULN (≤ 2.0X ULN for Gilbert's Disease with approval); ALT and AST ≤ 100 U/L

Cardiac function

Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 47% by radionuclide angiogram

Participants must have normal organ and marrow function as defined below: ... (see full text for details)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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