Active — Not RecruitingPhase 1

Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma

United States33 participantsStarted 2017-06-12

Plain-language summary

This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor (GM-CSF) in children with relapsed PFEPN

Who can participate

Age range12 Months – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and
✓. Serum glutamic oxaloacetic transaminase (SGOT) (AST) or serum glutamate pyruvate transaminase (SGPT) (ALT) \< 3 x upper limit of normal (ULN) for age
✓. Peripheral absolute neutrophil count (ANC) ≥1,000/µL
✓. Platelet count ≥100,000/µL (transfusion independent)
✓. Shortening fraction \> 28% by echocardiogram or
✓. Ejection fraction \> 50% by echocardiogram or radionuclide study

Exclusion criteria

✕. Pregnant or breast-feeding women are NOT eligible. Pregnancy tests must be obtained in females who are post-menarchal.
✕. Women of childbearing potential and male participants with partners of childbearing potential must agree to:

What they're measuring

Stratum 1: Detection of trastuzumab in tumor following IT administration

Timeframe: 2 weeks

Stratum 2: Determine the Maximum Tolerated Dose (MTD) for IT trastuzumab in combination with fixed doses of subQ GM-CSF

Timeframe: 1 month

Trial details

NCT IDNCT02774421

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-27

View on ClinicalTrials.gov More Posterior Fossa Ependymoma (PFEPN) trials