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 (Jun 2026). This Early Phase 1 trial studies multiple treatments for cns embryonal tumor.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Endocrine / hormonal
Other
Cancer type
Glioblastoma
Neuroblastoma
Biomarker criteria
Required: SMARCB1 INI-1 intact
CNS embryonal tumor with rhabdoid features (INI-1 intact)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT06942039 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require SMARCB1?
Yes, SMARCB1 INI-1 intact is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 6 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages