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Cytokine

Trastuzumab + GM-CSF for Ependymoma

Phase 1

Recruiting

Led By Kathleen Dorris, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 12 months and < 21 years at the time of study enrollment

Patients must be diagnosed with relapse of previously histologically confirmed PFEPN

Must not have

Patients with uncontrolled serious infection are NOT eligible for either Stratum

Patients with a diagnosis of specific ependymoma types are NOT eligible for either Stratum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a single dose of intrathecal trastuzumab, given with subcutaneous Granulocyte-macrophage colony-stimulating factor, can help children with relapsed posterior fossa ependymoma by detecting the presence of trastuzumab in tumor specimens.

Who is the study for?

This trial is for children and young adults aged between 1 and 21 years with a specific type of brain tumor called relapsed posterior fossa ependymoma. They must have good organ function, no widespread cancer in the spine or brain, and be able to undergo surgery if needed. Participants need acceptable performance scores indicating they can perform daily activities.

What is being tested?

The study tests how well trastuzumab, given through the spinal canal after a dose of GM-CSF under the skin, works on this kind of brain tumor. It aims to see if trastuzumab reaches the tumor and assesses any side effects when combined with GM-CSF.

What are the potential side effects?

Possible side effects include reactions at injection sites, flu-like symptoms from GM-CSF such as fever or muscle aches, allergic responses to trastuzumab including rash or breathing difficulties, and potential impact on blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 20 years old.

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My PFEPN cancer has come back.

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My brain MRI shows cancer hasn't spread widely in my brain or blocked fluid flow.

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I need surgery for my relapsed PFEPN tumor to join Stratum 1.

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I can take care of myself but may not be able to do active work or play.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious infections that are uncontrolled.

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I do not have a specific type of ependymoma.

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I am not on any medications that would disqualify me from the study.

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I do not have serious heart disease, risk factors, or uncontrolled heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stratum 1: Detection of trastuzumab in tumor following IT administration

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: IT trastuzumab in combination with subQ GM-CSFExperimental Treatment1 Intervention

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.

Group II: IT trastuzumab after subQ GM-CSFExperimental Treatment1 Intervention

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.

0 / 9Eligibility criteria met