Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma
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|ClinicalTrials.gov Identifier: NCT02774421|
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : December 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Posterior Fossa Ependymoma (PFEPN)||Drug: Trastuzumab after SubQ GM-CSF Drug: Trastuzumab in combination with SubQ GM-CSF||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||November 2025|
|Estimated Study Completion Date :||March 2026|
Experimental: IT trastuzumab after subQ GM-CSF
Patients with localized recurrent PFEPN will be treated with IT trastuzumab following 5-day course of subQ GM-CSF. Surgical resection should be planned (based on institutional surgical scheduling standards) for ideally 2-7 days after IT trastuzumab dosage.
Drug: Trastuzumab after SubQ GM-CSF
Experimental: IT trastuzumab in combination with subQ GM-CSF
Patients with localized recurrent PFEPN will be treated with IT trastuzumab in combination with GM-CSF to establish a maximum tolerated dosage. GM-CSF will be administered at 250 mcg/m2/dose subQ daily for three (3) days prior to the IT trastuzumab dose.
Drug: Trastuzumab in combination with SubQ GM-CSF
- Stratum 1: Detection of trastuzumab in tumor following IT administration [ Time Frame: 2 weeks ]The presence of trastuzumab will be measured as a binary (yes/no) outcome.
- Stratum 2: Determine the Maximum Tolerated Dose (MTD) for IT trastuzumab in combination with fixed doses of subQ GM-CSF [ Time Frame: 1 month ]The estimated MTD would be the highest dose at which 0/3 or 1/6 subjects experience a Dose Limiting Toxicity (DLT).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774421
|Contact: Melissa Widener, PAfirstname.lastname@example.org|
|Contact: Deb Schissel, RNemail@example.com|
|Principal Investigator:||Kathleen Dorris, MD||University of Colorado, Denver|