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

NCT02774421 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-21

No results posted yet for this study

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

Conditions

  • Posterior Fossa Ependymoma (PFEPN)

Interventions

DRUG

Trastuzumab after SubQ GM-CSF

Administration of trastuzumab following subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). Trastuzumab is a monoclonal antibody targeting HER2-positive cancers, commonly used in breast and gastric cancer treatment.

DRUG

Trastuzumab in combination with SubQ GM-CSF

Combine trastuzumab, a monoclonal antibody targeting HER2-positive cancers, with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF functions as an immune system modulator, promoting the activation and proliferation of dendritic cells, macrophages, and granulocytes.

Sponsors & Collaborators

  • Children's Hospital Colorado

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Margaret Macy, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2025-02-27
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02774421 on ClinicalTrials.gov