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Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma | Clinical Trials | Clareo Health

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

NCT02774421•University of Colorado, Denver

View on ClinicalTrials.gov

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

Eligibility

Age

1 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 12 months and \< 21 years at the time of study enrollment
•Patients must be diagnosed with relapse of previously histologically confirmed PFEPN
•Magnetic resonance (MR) imaging of the brain (performed within 14 days of enrollment) must demonstrate no evidence of diffuse leptomeningeal spread beyond the primary relapse site in posterior fossa and no obstruction of cerebrospinal fluid flow (CSF).
•MR imaging of the total spine (performed within 14 days of enrollment) demonstrates no evidence of spinal metastatic disease.
•Patients must have clinical indication for standard of care surgical resection of relapsed PFEPN tumor for enrollment in Stratum 1
•Patients must meet one of the following performance scores:
•* Eastern Cooperative Oncology Group (ECOG) performance status scores of 0, 1, or 2;
•* Karnofsky score of ≥ 50 for patients \> 16 years of age; or
•* Lansky score of ≥ 50 for patients ≤ 16 years of age.
•Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
+15 more criteria

Exclusion Criteria

•Patients with a diagnosis of:
•* spinal cord ependymoma,
•* myxopapillary ependymoma,
•* subependymoma,
•* ependymoblastoma,
•* supratentorial ependymoma, or
•Prior Therapy:
•* Monoclonal antibodies: At least three (3) half-lives of the antibody must have elapsed since the last dose of a monoclonal antibody (see Appendix I for list of half-lives)
•* Surgical resection: Must have fully healed from any surgical procedure to be safe for lumbar puncture according to treating neurosurgeon and at least 14 days should have elapsed since the surgical procedure.
•Concomitant Medications
+8 more criteria

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Key Dates

Start Date

June 12, 2017

Primary Completion Date

February 27, 2025

Completion Date

March 1, 2026

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Posterior Fossa Ependymoma (PFEPN)

Interventions

Trastuzumab after SubQ GM-CSF

DRUG

Trastuzumab in combination with SubQ GM-CSF

DRUG